ClinicalTrials.gov
ClinicalTrials.gov Menu

Trial of Sertraline to Treat Children With Fragile X Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01474746
Recruitment Status : Completed
First Posted : November 18, 2011
Results First Posted : September 25, 2017
Last Update Posted : September 25, 2017
Sponsor:
Information provided by (Responsible Party):
Randi J. Hagerman, MD, University of California, Davis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Fragile X Syndrome
Interventions Drug: Sertraline
Drug: Placebo
Enrollment 57

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Active
Hide Arm/Group Description

This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.

Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months.

This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.

Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months.

Period Title: Overall Study
Started 30 27
Completed 27 25
Not Completed 3 2
Reason Not Completed
Lost to Follow-up             1             1
Withdrawal by Subject             2             1
Arm/Group Title Placebo Active Total
Hide Arm/Group Description

This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.

Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months.

This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.

Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months.

Total of all reporting groups
Overall Number of Baseline Participants 30 27 57
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 27 participants 57 participants
<=18 years
30
 100.0%
27
 100.0%
57
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 27 participants 57 participants
Female
3
  10.0%
6
  22.2%
9
  15.8%
Male
27
  90.0%
21
  77.8%
48
  84.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants 27 participants 57 participants
30 27 57
1.Primary Outcome
Title Change in Mullen Scales of Early Learning - Expressive Language Raw Score
Hide Description The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language. Shown here are the baseline and 6-month follow-up raw scores from the expressive language scale. This scale's raw scores range from 0 to 50. The lower the score on this scale, the weaker the ability; the higher the score, the greater the ability. The MSEL was administered at the baseline visit and at the 6-month follow-up visit.
Time Frame From baseline visit to six-month visit.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Two subjects from the sertraline arm discontinued - 1 lost to follow up, 1 withdrew consent Three subjects from the placebo arm discontinued - 1 lost to follow up, 2 withdrew consent
Arm/Group Title Placebo Active
Hide Arm/Group Description:

This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.

Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months.

This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.

Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months.

Overall Number of Participants Analyzed 27 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 19.3  (9.68) 21.3  (10.32)
Follow-Up 21.3  (9.59) 25.04  (10.78)
2.Primary Outcome
Title Clinical Global Impression - Improvement
Hide Description The Clinical Global Impression - Improvement (CGI-I) is used to measure the overall behavioral change of an individual and their therapeutic response. The CGI-I is a 3-item observer-rated scale administered by the physician to the caregiver, who assesses improvement using a 7-point scale: 1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 = Minimally worse; 6 = Much worse; and 7 = Very much worse. Therefore, the lower the score, the greater the behavioral improvement as rated by the caregiver. Shown here are the CGI-I mean scores from the 6-month follow-up visit.
Time Frame 6-month follow-up visit score
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Two subjects from the sertraline arm discontinued - 1 lost to follow up, 1 withdrew consent Three subjects from the placebo arm discontinued - 1 lost to follow up, 2 withdrew consent
Arm/Group Title Placebo Active
Hide Arm/Group Description:

This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.

Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months.

This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.

Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months.

Overall Number of Participants Analyzed 27 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.59  (0.84) 2.28  (1.06)
3.Primary Outcome
Title Change in Mullen Scales of Early Learning - Expressive Language Standard T Score
Hide Description The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language and expressive language. Based on the raw score obtained by the participant in each scale the scoring software computes T scores, percentile ranks, and age equivalents for each scale separately. Shown here are the baseline and 6-month follow-up T scores from the expressive language scale. T scores have a range of 20 to 80, a mean of 50, and a standard deviation of 10. Any child scoring at or below 1.5 standard deviations below the average is considered presenting significant delays. The lower the T score, the worse the outcome. The MSEL was administered at the baseline visit and at the 6-month follow-up visit.
Time Frame From baseline visit to six-month visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Two subjects from the sertraline arm discontinued - 1 lost to follow up, 1 withdrew consent Three subjects from the placebo arm discontinued - 1 lost to follow up, 2 withdrew consent
Arm/Group Title Placebo Active
Hide Arm/Group Description:

This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.

Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months.

This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.

Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months.

Overall Number of Participants Analyzed 27 25
Mean (Standard Deviation)
Unit of Measure: T scores
Baseline 23.3  (5.8) 25.8  (11.78)
6-Month Follow-Up 22.6  (6.47) 25.8  (10.87)
4.Secondary Outcome
Title Autism Diagnostic Observation Schedule
Hide Description The Autism Diagnostic Observation Schedule (ADOS-2) assesses and diagnoses autism spectrum disorder. This test was administered at baseline and at the six-month follow-up visit. The choice to administer Module 1 or Module 2 depends on the verbal ability of each subject: Module 1 is used for children who are 31 months and older and/or who do not consistently use phrase speech, and Module 2 is used for children of any age who use phrase speech but are not verbally fluent. The scoring algorithm gives an overall total, which ranges from 0 to 28. The higher the score, the higher the level of autism-related symptoms. The overall total ranges from 0 to 28. On Module 1, for children with few to no words, scores at 11 and above indicate autism spectrum; for children with some words, the cutoff is scores 8 and above. On Module 2, the cutoff for autism spectrum is 7 or above for kids under 5 years, and 8 or above for those 5 years and older.
Time Frame At baseline visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ADOS was not administered to all subjects at baseline due to the PI's decision to remove this assessment from the protocol partway through the study; due to staff oversight, however, this assessment remained listed among the measures in the protocol.
Arm/Group Title Placebo Active
Hide Arm/Group Description:

This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.

Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months.

This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.

Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months.

Overall Number of Participants Analyzed 30 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
10.73  (6.23) 11.00  (6.57)
5.Secondary Outcome
Title Visual Analog Scale
Hide Description The Visual Analog Scale will be used to measure the severity of three specific behavioral symptoms chosen by the caregiver(s). Parents mark on a visual line measuring 10 cm with “worst behavior” at 0 cm and "best behavior” at 10 cm. The parents choose two key behaviors that they want to target for this trial (e.g., aggression, hyperarousal, anxiety, hyperactivity) and the third target measurement is language/communication. For each behavior the caregiver is instructed to mark their impression of the behavior at baseline visit and again at the 6-month visit. The calculated distance in cm between the baseline and 6-month visit marks thereby demonstrates whether each behavior improved, worsened, or stayed the same during the study, and by how much. Shown here is the mean distance in cm from the "worst behavior" side, at baseline. The smaller the value, the worse the behavior. The range is minimum 0 cm to maximum 10 cm.
Time Frame At baseline visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Active
Hide Arm/Group Description:

This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.

Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months.

This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.

Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months.

Overall Number of Participants Analyzed 30 27
Mean (Standard Deviation)
Unit of Measure: centimeters
2.95  (1.72) 2.62  (1.74)
6.Secondary Outcome
Title Eye Tracking
Hide Description There are several eye tracking measures, each intended to measure different outcomes including social gaze, social reciprocity, and attention. All stimuli are presented on a Tobii T120 binocular eye tracker monitor. The system consists of a high-resolution camera embedded in a 17-inch TFT monitor. Stimuli consist of sixty colored photographs of adult human face (equal numbers of males and females, different races and ethnicities) from the NimStim Face Stimulus Set, each showing a calm, happy, or fearful expression, and sixty scrambled versions of the face images. Shown here are the averaged response times (in seconds) to the presented stimuli, at the baseline visit.
Time Frame At baseline visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data were collected and analyzed on those participants who were compliant with the eye tracking protocol: 13 in the placebo group, and 9 in the active group.
Arm/Group Title Placebo Active
Hide Arm/Group Description:

This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.

Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months.

This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.

Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months.

Overall Number of Participants Analyzed 13 9
Mean (Standard Deviation)
Unit of Measure: seconds
0.510136154  (0.056) 0.451205556  (0.07)
7.Secondary Outcome
Title Preschool Language Scale-fifth Edition (PLS-5): AC+EC Total Raw Score
Hide Description The Preschool Language Scale-fifth edition (PLS-5) is designed to measure auditory comprehension (AC) and expressive communication (EC) for children birth to 7 years 11 months. The measure examines the child’s attention, play, gestures, social communication, semantics, language structure, integrative language skills and emergent literacy skills. The PLS-5 has expanded coverage of early play behaviors, concepts, Theory of Mind, as well as emergent literacy skills. The PLS-5 yields norm-referenced scores including standard scores, percentile ranks and age equivalents for the AC and EC scales as well as for Total Language (TL). Raw score ranges are 0 to 65 in AC, 0 to 67 in EC, and therefore 0 to 132 in TL (calculated by summing AC+EC raw scores). The higher the scores, the greater the language ability. Shown here are the mean TL raw scores from the baseline visit.
Time Frame At baseline visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Active
Hide Arm/Group Description:

This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.

Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months.

This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.

Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months.

Overall Number of Participants Analyzed 30 27
Mean (Standard Deviation)
Unit of Measure: units on a scale
53.90  (18.84) 55.59  (21.13)
8.Secondary Outcome
Title Sensory Processing Measure - Preschool (SPM-P) Social Participation: Raw Score
Hide Description The Sensory Processing Measure - Preschool (SPM-P) is a questionnaire that was used to measure specific problems, including under- and over-responsiveness, sensory-seeking behavior, and perceptual problems in multiple environments (at home, at school, and in the community) for children aged 2 to 5 years old. The SPM-P provides norm-referenced standard scores for two higher level integrative functions (praxis and social participation) and five sensor sensory systems (visual, auditory, tactile, proprioceptive, and vestibular functioning). Reported here is the Social Participation subscale mean raw score, which ranges from 8 to 32. The lower the raw score, the more limited the child's level of social participation. The higher the score, the greater the child's level of social participation.
Time Frame At baseline visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The SPM-P was removed from the protocol after the trial was initiated and was therefore not administered to 1 subject in the active treatment group at baseline.
Arm/Group Title Placebo Active
Hide Arm/Group Description:

This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.

Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months.

This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.

Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months.

Overall Number of Participants Analyzed 30 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
20.6  (6.85) 20.5  (5.49)
9.Secondary Outcome
Title Sensory Profile - Sensation Seeking Subscale Raw Score
Hide Description The Sensory Profile is designed to measure sensory-related difficulties. This measure will be administered to the primary caregiver of each subject to measure the caregiver’s sensory ability and its impact on the subject. Of the four subscales scored in the Sensory Profile, the "Sensation Seeking" subscale mean raw scores for the placebo and treatment groups are reported here. This subscale has a raw scores range from 0 to 95, with scores 0-6 indicating that the child is sensation seeking much less than others, 7-19 less than others, 20-47 just like the majority of others, 48-60 more than others, and 61-95 much more than others.
Time Frame At baseline visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Sensory Profile was not administered to all subjects at baseline due to the PI's decision to remove this assessment from the protocol partway through the study; due to staff oversight, however, this assessment remained listed among the measures in the protocol.
Arm/Group Title Placebo Active
Hide Arm/Group Description:

This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.

Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months.

This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.

Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months.

Overall Number of Participants Analyzed 22 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
47.86364  (7.97195) 47.83333  (7.69454)
10.Secondary Outcome
Title Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) - Adaptive Behavior Composite Standard Score
Hide Description The Vineland-II measures the personal and social skills of individuals from birth through adulthood. It was designed to assess handicapped and non-handicapped persons in their personal and social functioning and is appropriate for individuals of all ages. The Vineland-II is a survey that is administered to a parent or caregiver using a semi-structured interview format and is organized around four Behavior Domains: Communication, Daily Living Skills, Socialization, and Motor Skills. Each subtest is scored with a standard score X=100 ± 15 and summed to calculate the Adaptive Behavior Composite (ABC) using age-adjusted scoring tables. Reported here are the ABC mean standard scores for the placebo and treatment groups baseline. The ABC ranges from 20 to 160 and indicates low (20-70), moderately low (70-85), adequate (85-115), moderately high (115-130), or high (130-160) overall adaptive functioning.
Time Frame At baseline visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This assessment was introduced to the protocol partway through the study, and therefore there were only 20 subjects (10 placebo and 10 active) who were administered the Vineland-II at both their baseline and follow-up visits.
Arm/Group Title Placebo Active
Hide Arm/Group Description:

This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.

Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months.

This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.

Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months.

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
73.3  (10.08905) 66.5  (16.84076)
11.Secondary Outcome
Title Mullen Scales of Early Learning - Visual Reception Raw Score
Hide Description The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language. Shown here are the mean baseline raw scores from the Visual Reception scale. This scale's raw scores range from 0 to 50. The lower the score on this scale, the weaker the child's ability for visual reception; the higher the score, the greater the ability for visual reception.
Time Frame At baseline visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Active
Hide Arm/Group Description:

This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.

Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months.

This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.

Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months.

Overall Number of Participants Analyzed 30 27
Mean (Standard Deviation)
Unit of Measure: units on a scale
28.9  (7.94) 26.3  (9.50)
12.Secondary Outcome
Title Mullen Scales of Early Learning - Fine Motor Raw Score
Hide Description The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language. Shown here are the mean raw scores from the Fine Motor scale at the baseline visit. This scale's raw scores range from 0 to 49. The lower the score on this scale, the weaker the child's fine motor skills; the higher the score, the greater the child's fine motor skills.
Time Frame At baseline visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Active
Hide Arm/Group Description:

This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.

Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months.

This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.

Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months.

Overall Number of Participants Analyzed 30 27
Mean (Standard Deviation)
Unit of Measure: units on a scale
24.8  (5.26) 23.1  (7.13)
13.Secondary Outcome
Title The Autism Diagnostic Observation Schedule (ADOS-2)
Hide Description The Autism Diagnostic Observation Schedule (ADOS-2) assesses and diagnoses autism spectrum disorder. This test was administered at baseline and at the six-month follow-up visit. The choice to administer Module 1 or Module 2 depends on the verbal ability of each subject: Module 1 is used for children who are 31 months and older and/or who do not consistently use phrase speech, and Module 2 is used for children of any age who use phrase speech but are not verbally fluent. The scoring algorithm gives an overall total, which ranges from 0 to 28. The higher the score, the higher the level of autism-related symptoms. The overall total ranges from 0 to 28. On Module 1, for children with few to no words, scores at 11 and above indicate autism spectrum; for children with some words, the cutoff is scores 8 and above. On Module 2, the cutoff for autism spectrum is 7 or above for kids under 5 years, and 8 or above for those 5 years and older.
Time Frame At six month visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ADOS was not administered to all subjects at the six-month visit due to the PI's decision to remove this assessment from the protocol partway through the study; due to staff oversight, however, the ADOS remained listed in the protocol. Also, 2 sertraline and 3 placebo subjects discontinued and were thus administered no follow-up ADOS.
Arm/Group Title Placebo Active
Hide Arm/Group Description:

This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.

Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months.

This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.

Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months.

Overall Number of Participants Analyzed 26 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
11.00  (5.31) 11.67  (6.59)
14.Secondary Outcome
Title The Visual Analog Scale
Hide Description The Visual Analog Scale will be used to measure the severity of three specific behavioral symptoms chosen by the caregiver(s). Parents mark on a visual line measuring 10 cm with “worst behavior” at 0 cm and "best behavior” at 10 cm. The parents choose two key behaviors that they want to target for this trial (e.g., aggression, hyperarousal, anxiety, hyperactivity) and the third target measurement is language/communication. For each behavior the caregiver is instructed to mark their impression of the behavior at baseline visit and again at the 6-month visit. The calculated distance in cm between the baseline and 6-month visit marks thereby demonstrates whether each behavior improved, worsened, or stayed the same during the study, and by how much. Shown here is the mean distance in cm from the "worst behavior" side, at the 6-month visit. The smaller the value, the worse the behavior. The range is minimum 0 cm to maximum 10 cm.
Time Frame At six-month visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Two subjects from the sertraline arm discontinued - 1 lost to follow up, 1 withdrew consent. An additional subject from the sertraline arm was not administered this measure at the 6-month visit due to staff oversight.

Three subjects from the placebo arm discontinued - 1 lost to follow up, 2 withdrew consent

Arm/Group Title Placebo Active
Hide Arm/Group Description:

This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.

Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months.

This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.

Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months.

Overall Number of Participants Analyzed 27 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.16  (2.03) 5.58  (2.58)
15.Secondary Outcome
Title Eye Tracking
Hide Description There are several eye tracking measures, each intended to measure different outcomes including social gaze, social reciprocity, and attention. All stimuli are presented on a Tobii T120 binocular eye tracker monitor. The system consists of a high-resolution camera embedded in a 17-inch TFT monitor. Stimuli consist of sixty colored photographs of adult human face (equal numbers of males and females, different races and ethnicities) from the NimStim Face Stimulus Set, each showing a calm, happy, or fearful expression, and sixty scrambled versions of the face images. Shown here are the averaged response times (in seconds) to the presented stimuli, at the 6-month follow-up visit.
Time Frame At six-month visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data were collected and analyzed on those participants who were compliant with the eye tracking protocol: 13 in the placebo group, and 9 in the active group.
Arm/Group Title Placebo Active
Hide Arm/Group Description:

This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.

Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months.

This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.

Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months.

Overall Number of Participants Analyzed 13 9
Mean (Standard Deviation)
Unit of Measure: seconds
0.505969231  (0.08) 0.538312222  (0.095)
16.Secondary Outcome
Title Preschool Language Scale-fifth Edition (PLS-5): AC+EC Total Raw Score
Hide Description The Preschool Language Scale-fifth edition (PLS-5) is designed to measure auditory comprehension (AC) and expressive communication (EC) for children birth to 7 years 11 months. The measure examines the child’s attention, play, gestures, social communication, semantics, language structure, integrative language skills and emergent literacy skills. The PLS-5 has expanded coverage of early play behaviors, concepts, Theory of Mind, as well as emergent literacy skills. The PLS-5 yields norm-referenced scores including standard scores, percentile ranks and age equivalents for the AC and EC scales as well as for Total Language (TL). Raw score ranges are 0 to 65 in AC, 0 to 67 in EC, and therefore 0 to 132 in TL (calculated by summing AC+EC raw scores). The higher the scores, the greater the language ability. Shown here are the mean TL raw scores from the 6-month follow-up visit.
Time Frame At six-month visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Two subjects from the sertraline arm discontinued - 1 lost to follow up, 1 withdrew consent Three subjects from the placebo arm discontinued - 1 lost to follow up, 2 withdrew consent
Arm/Group Title Placebo Active
Hide Arm/Group Description:

This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.

Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months.

This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.

Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months.

Overall Number of Participants Analyzed 27 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
59.89  (18.11) 62.80  (21.70)
17.Secondary Outcome
Title Sensory Processing Measure-Preschool (SPM-P) Social Participation: Raw Score
Hide Description The Sensory Processing Measure - Preschool (SPM-P) is a questionnaire that was used to measure specific problems, including under- and over-responsiveness, sensory-seeking behavior, and perceptual problems in multiple environments (at home, at school, and in the community) for children aged 2 to 5 years old. The SPM-P provides norm-referenced standard scores for two higher level integrative functions (praxis and social participation) and five sensor sensory systems (visual, auditory, tactile, proprioceptive, and vestibular functioning). The SPM-P was administered to the caregiver at baseline and again at the 6-month follow-up visit. Reported here is the Social Participation subscale mean raw score from the 6-month visit, which ranges from 8 to 32. The lower the raw score, the more limited the child's level of social participation. The higher the score, the greater the child's level of social participation.
Time Frame At six-month visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
2 subjects from the sertraline arm discontinued - 1 lost to follow up, 1 withdrew consent. 3 subjects from the placebo arm discontinued - 1 lost to follow up, 2 withdrew consent. The SPM-P was removed from the protocol after the trial was initiated and was therefore not administered to 4 placebo and 3 treatment recipients at the 6-month visit.
Arm/Group Title Placebo Active
Hide Arm/Group Description:

This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.

Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months.

This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.

Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months.

Overall Number of Participants Analyzed 23 22
Mean (Standard Deviation)
Unit of Measure: units on a scale
19.7  (6.41) 18.0  (6.23)
18.Secondary Outcome
Title Sensory Profile - Sensation Seeking Subscale Raw Score
Hide Description The Sensory Profile is designed to measure sensory-related difficulties. This measure will be administered to the primary caregiver of each subject to measure the caregiver’s sensory ability and its impact on the subject. Of the four subscales scored in the Sensory Profile, the "Sensation Seeking" subscale mean raw scores for the placebo and treatment groups are reported here. This subscale has a raw scores range from 0 to 95, with scores 0-6 indicating that the child is sensation seeking much less than others, 7-19 less than others, 20-47 just like the majority of others, 48-60 more than others, and 61-95 much more than others.
Time Frame At six-month visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Sensory Profile assessment was not administered to any subjects at the follow-up visit due to revisions to the protocol.
Arm/Group Title Placebo Active
Hide Arm/Group Description:

This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.

Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months.

This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.

Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
19.Secondary Outcome
Title Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) Adaptive Behavior Composite Standard Score
Hide Description The Vineland-II measures the personal and social skills of individuals from birth through adulthood. It was designed to assess handicapped and non-handicapped persons in their personal and social functioning and is appropriate for individuals of all ages. The Vineland-II is a survey that is administered to a parent or caregiver using a semi-structured interview format and is organized around four Behavior Domains: Communication, Daily Living Skills, Socialization, and Motor Skills. Each subtest is scored with a standard score X=100 ± 15 and summed to calculate the Adaptive Behavior Composite (ABC) using age-adjusted scoring tables. Reported here are the ABC mean standard scores for the placebo and treatment groups at the 6-month visit. The ABC ranges from 20 to 160 and indicates low (20-70), moderately low (70-85), adequate (85-115), moderately high (115-130), or high (130-160) overall adaptive functioning.
Time Frame At six-month visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This assessment was only introduced to the protocol partway through the trial. As such, only 20 subjects (10 placebo, 10 active) were administered the Vineland-2 at both baseline and follow-up visits.
Arm/Group Title Placebo Active
Hide Arm/Group Description:

This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.

Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months.

This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.

Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months.

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
74.5  (7.50185) 66.4  (17.68364)
20.Secondary Outcome
Title Mullen Scales of Early Learning - Visual Reception Raw Score
Hide Description The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language. Shown here are the mean raw scores from the Visual Reception scale at the 6-month follow-up visit. This scale's raw scores range from 0 to 50. The lower the score on this scale, the weaker the child's ability for visual reception; the higher the score, the greater the ability for visual reception.
Time Frame At six-month visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Two subjects from the sertraline arm discontinued - 1 lost to follow up, 1 withdrew consent Three subjects from the placebo arm discontinued - 1 lost to follow up, 2 withdrew consent
Arm/Group Title Placebo Active
Hide Arm/Group Description:

This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.

Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months.

This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.

Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months.

Overall Number of Participants Analyzed 27 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
30.9  (6.73) 32.4  (10.46)
21.Secondary Outcome
Title Mullen Scales of Early Learning - Visual Reception Age-equivalent Score
Hide Description The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language. Shown here are the mean baseline age-equivalent scores from the Visual Reception scale. This scale's age-equivalent scores for each of the five scales are calculated from the raw scores for each scale, using the MSEL Age Equivalents table. Age-equivalent scores for each scale range from 0 to 70 months, with lower scores indicating that a child's visual reception is at a level typical of younger ages, and higher scores indicating that a child's visual reception is at a level typical of older ages.
Time Frame At baseline visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Active
Hide Arm/Group Description:

This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.

Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months.

This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.

Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months.

Overall Number of Participants Analyzed 30 27
Mean (Standard Deviation)
Unit of Measure: months
28.2  (10.53) 25.3  (11.59)
22.Secondary Outcome
Title Mullen Scales of Early Learning - Visual Reception Age-equivalent Score
Hide Description The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language. Shown here are the mean age-equivalent scores from the Visual Reception scale at the 6-month follow-up visit. This scale's age-equivalent scores for each of the five scales are calculated from the raw scores for each scale, using the MSEL Age Equivalents table. Age-equivalent scores for each scale range from 0 to 70 months, with lower scores indicating that a child's visual reception is at a level typical of younger ages, and higher scores indicating that a child's visual reception is at a level typical of older ages.
Time Frame At six-month visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Two subjects from the sertraline arm discontinued - 1 lost to follow up, 1 withdrew consent Three subjects from the placebo arm discontinued - 1 lost to follow up, 2 withdrew consent
Arm/Group Title Placebo Active
Hide Arm/Group Description:

This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.

Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months.

This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.

Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months.

Overall Number of Participants Analyzed 27 25
Mean (Standard Deviation)
Unit of Measure: months
30.6  (9.60) 33.7  (15.06)
23.Secondary Outcome
Title Mullen Scales of Early Learning - Fine Motor Raw Score
Hide Description The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language. Shown here are the mean raw scores from the Fine Motor scale at the 6-month follow-up visit. This scale's raw scores range from 0 to 49. The lower the score on this scale, the weaker the child's fine motor skills; the higher the score, the greater the child's fine motor skills.
Time Frame At six-month visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Two subjects from the sertraline arm discontinued - 1 lost to follow up, 1 withdrew consent Three subjects from the placebo arm discontinued - 1 lost to follow up, 2 withdrew consent
Arm/Group Title Placebo Active
Hide Arm/Group Description:

This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.

Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months.

This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.

Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months.

Overall Number of Participants Analyzed 27 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
25.2  (4.96) 27.3  (8.06)
24.Secondary Outcome
Title Mullen Scales of Early Learning - Fine Motor Age-equivalent Score
Hide Description The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language. Shown here are the mean baseline age-equivalent scores from the Fine Motor scale. This scale's age-equivalent scores for each of the five scales are calculated from the raw scores for each scale, using the MSEL Age Equivalents table. Age-equivalent scores for each scale range from 0 to 70 months, with lower scores indicating that a child's fine motor skills are at a level typical of younger ages, and higher scores indicating that a child's fine motor skills are at a level typical of older ages.
Time Frame At baseline visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Active
Hide Arm/Group Description:

This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.

Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months.

This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.

Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months.

Overall Number of Participants Analyzed 30 27
Mean (Standard Deviation)
Unit of Measure: months
24.5  (6.97) 22.7  (8.66)
25.Secondary Outcome
Title Mullen Scales of Early Learning - Fine Motor Age-equivalent Score
Hide Description The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language. Shown here are the mean age-equivalent scores from the Fine Motor scale at the 6-month follow-up visit. This scale's age-equivalent scores for each of the five scales are calculated from the raw scores for each scale, using the MSEL Age Equivalents table. Age-equivalent scores for each scale range from 0 to 70 months, with lower scores indicating that a child's fine motor skills are at a level typical of younger ages, and higher scores indicating that a child's fine motor skills are at a level typical of older ages.
Time Frame At six-month visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Two subjects from the sertraline arm discontinued - 1 lost to follow up, 1 withdrew consent Three subjects from the placebo arm discontinued - 1 lost to follow up, 2 withdrew consent
Arm/Group Title Placebo Active
Hide Arm/Group Description:

This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.

Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months.

This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.

Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months.

Overall Number of Participants Analyzed 27 25
Mean (Standard Deviation)
Unit of Measure: months
25.0  (6.91) 28.4  (10.91)
26.Secondary Outcome
Title Mullen Scales of Early Learning - Cognitive T Score Sum
Hide Description The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor (not administered because it was out of age range for most subjects), visual reception, fine motor, receptive language and expressive language. Based on the raw score obtained by the participant in each scale, the scoring software computes T scores for each scale separately. Each scale's T score has a range of 20 to 80, a mean of 50, and a standard deviation of 10, and the lower the T score, the lower the child's cognitive and developmental ability. Cognitive T score sum is the sum of the T scores for each scale administered; since 4 scales were administered, the sum's range is 80 to 320, with lower sums indicating lower overall ability. The MSEL was administered at the baseline visit and at the 6-month follow-up visit, and mean baseline cognitive T score sums for the placebo and treatment groups are shown here.
Time Frame At baseline visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Active
Hide Arm/Group Description:

This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.

Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months.

This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.

Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months.

Overall Number of Participants Analyzed 30 27
Mean (Standard Deviation)
Unit of Measure: T scores
96.0  (21.97) 99.7  (33.46)
27.Secondary Outcome
Title Mullen Scales of Early Learning - Cognitive T Score Sum
Hide Description The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor (not administered because it was out of age range for most subjects), visual reception, fine motor, receptive language and expressive language. Based on the raw score obtained by the participant in each scale, the scoring software computes T scores for each scale separately. Each scale's T score has a range of 20 to 80, a mean of 50, and a standard deviation of 10, and the lower the T score, the lower the child's cognitive and developmental ability. Cognitive T score sum is the sum of the T scores for each scale administered; since 4 scales were administered, the sum's range is 80 to 320, with lower sums indicating lower overall ability. The MSEL was administered at the baseline and 6-month follow-up visits, and mean cognitive T score sums from the 6-month follow-up visit for the placebo and treatment groups are shown here.
Time Frame At six-month visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Two subjects from the sertraline arm discontinued - 1 lost to follow up, 1 withdrew consent Three subjects from the placebo arm discontinued - 1 lost to follow up, 2 withdrew consent
Arm/Group Title Placebo Active
Hide Arm/Group Description:

This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.

Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months.

This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.

Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months.

Overall Number of Participants Analyzed 27 25
Mean (Standard Deviation)
Unit of Measure: T scores
93.0  (20.33) 105.4  (40.27)
28.Secondary Outcome
Title Mullen Scales of Early Learning - Summary Age-equivalent Score
Hide Description The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language and expressive language. Based on the raw score obtained by the participant in each scale, the scoring software computes T scores, percentile ranks, and age equivalents for each scale separately, as well as a cognitive T score sum and summary age-equivalent score to characterize overall early developmental ability. Summary age-equivalent scores range from 0 to 70 months, with lower scores indicating that a child's ability is at a level typical of younger ages, and higher scores indicating that a child's ability is at a level typical of older ages. The MSEL was administered at the baseline visit and at the 6-month follow-up visit, and mean baseline summary age-equivalent scores for the placebo and treatment groups are shown here.
Time Frame At baseline visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Active
Hide Arm/Group Description:

This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.

Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months.

This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.

Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months.

Overall Number of Participants Analyzed 30 27
Mean (Standard Deviation)
Unit of Measure: months
24.8  (9.33) 26.8  (8.89)
29.Secondary Outcome
Title Mullen Scales of Early Learning - Summary Age-equivalent Score
Hide Description The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language and expressive language. Based on the raw score obtained by the participant in each scale, the scoring software computes T scores, percentile ranks, and age equivalents for each scale separately, as well as a cognitive T score sum and summary age-equivalent score to characterize overall early developmental ability. Summary age-equivalent scores range from 0 to 70 months, with lower scores indicating that a child's ability is at a level typical of younger ages, and higher scores indicating that a child's ability is at a level typical of older ages. The MSEL was administered at the baseline visit and at the 6-month follow-up visit, and mean summary age-equivalent scores at the 6-month follow-up visit for the placebo and treatment groups are shown here.
Time Frame At six-month visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Two subjects from the sertraline arm discontinued - 1 lost to follow up, 1 withdrew consent Three subjects from the placebo arm discontinued - 1 lost to follow up, 2 withdrew consent
Arm/Group Title Placebo Active
Hide Arm/Group Description:

This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.

Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months.

This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.

Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months.

Overall Number of Participants Analyzed 27 25
Mean (Standard Deviation)
Unit of Measure: months
23.6  (10.76) 30.1  (12.64)
Time Frame The adverse event data were collected via non-systematic assessment (based on parent/caregiver reporting) throughout the 6-month period of each subject's participation in the study, as well as via systematic assessment (physical exams) at the baseline, 3-month, and 6-month timepoints.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Active
Hide Arm/Group Description

This arm will undergo identical treatment and assessments as the experimental group, with the exception of the active agent, sertraline. This group will be placed on a placebo.

Placebo: The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months.

This arm will undergo identical treatment and assessments as the placebo group. This group will receive the active agent, sertraline.

Sertraline: Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months.

All-Cause Mortality
Placebo Active
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)      0/27 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Active
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/30 (0.00%)      0/27 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Active
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   26/30 (86.67%)      25/27 (92.59%)    
Blood and lymphatic system disorders     
Bruising *  1/30 (3.33%)  1 0/27 (0.00%)  0
Ear and labyrinth disorders     
Ear infection *  5/30 (16.67%)  8 3/27 (11.11%)  5
Endocrine disorders     
Sweating *  1/30 (3.33%)  2 0/27 (0.00%)  0
Eye disorders     
Eye infection *  1/30 (3.33%)  1 1/27 (3.70%)  1
Dilated pupils *  1/30 (3.33%)  1 0/27 (0.00%)  0
Gastrointestinal disorders     
Nausea *  3/30 (10.00%)  3 1/27 (3.70%)  1
Vomiting *  10/30 (33.33%)  17 8/27 (29.63%)  8
GI upset *  5/30 (16.67%)  5 5/27 (18.52%)  5
Diarrhea *  17/30 (56.67%)  29 12/27 (44.44%)  20
General disorders     
Decreased verbalization *  1/30 (3.33%)  1 0/27 (0.00%)  0
Deciduous teeth eruption *  1/30 (3.33%)  1 0/27 (0.00%)  0
Drooling   1/30 (3.33%)  1 1/27 (3.70%)  1
Biting clothing *  1/30 (3.33%)  1 0/27 (0.00%)  0
Sleep disturbance *  1/30 (3.33%)  1 1/27 (3.70%)  1
Headache *  2/30 (6.67%)  2 0/27 (0.00%)  0
Bruxism *  0/30 (0.00%)  0 1/27 (3.70%)  1
Drowsiness/Tiredness *  5/30 (16.67%)  6 3/27 (11.11%)  3
Infections and infestations     
Upper respiratory infection *  20/30 (66.67%)  31 14/27 (51.85%)  24
Injury, poisoning and procedural complications     
Self-injurious behavior *  1/30 (3.33%)  1 0/27 (0.00%)  0
Falling *  0/30 (0.00%)  0 1/27 (3.70%)  1
Investigations     
Abnormal Electroencephalogram *  1/30 (3.33%)  1 0/27 (0.00%)  0
Metabolism and nutrition disorders     
Loss of appetite *  4/30 (13.33%)  5 4/27 (14.81%)  4
Nervous system disorders     
Tremor *  1/30 (3.33%)  1 0/27 (0.00%)  0
Seizures *  1/30 (3.33%)  1 0/27 (0.00%)  0
Psychiatric disorders     
Tantrums *  1/30 (3.33%)  1 0/27 (0.00%)  0
Hand flapping *  1/30 (3.33%)  1 0/27 (0.00%)  0
Irritability *  0/30 (0.00%)  0 1/27 (3.70%)  1
Aggression *  1/30 (3.33%)  1 1/27 (3.70%)  1
Nervousness *  1/30 (3.33%)  1 1/27 (3.70%)  2
Anxiety *  2/30 (6.67%)  2 0/27 (0.00%)  0
Hyperactivity *  4/30 (13.33%)  4 3/27 (11.11%)  4
Renal and urinary disorders     
Genital infection *  1/30 (3.33%)  1 0/27 (0.00%)  0
Skin and subcutaneous tissue disorders     
Dry skin *  1/30 (3.33%)  1 0/27 (0.00%)  0
Rash *  2/30 (6.67%)  2 5/27 (18.52%)  6
*
Indicates events were collected by non-systematic assessment
Indicates events were collected by systematic assessment
Several secondary analyses. Subject non-compliance with eye tracking led to unreliable/uninterpretable data. Subjects and caregivers were unblinded at the time they completed the study. Limited number of girls in the study (total 9 girls).
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Randi Hagerman
Organization: University of California, Davis, MIND Institute
Phone: 916-703-0247
Responsible Party: Randi J. Hagerman, MD, University of California, Davis
ClinicalTrials.gov Identifier: NCT01474746     History of Changes
Other Study ID Numbers: 271070
R40MC22641 ( Other Grant/Funding Number: Health Resources and Services Administration (HRSA) )
First Submitted: November 10, 2011
First Posted: November 18, 2011
Results First Submitted: March 27, 2017
Results First Posted: September 25, 2017
Last Update Posted: September 25, 2017