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Early Intervention With Fluoxetine in Autism

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ClinicalTrials.gov Identifier: NCT00183339
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : March 26, 2014
Last Update Posted : March 26, 2014
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Linmarie Sikich, MD, University of North Carolina, Chapel Hill

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Autistic Disorder
Interventions Drug: Fluoxetine
Drug: Placebo
Enrollment 18

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Fluoxetine
Hide Arm/Group Description Participants who received placebo solution between .5ml and 5.0ml Participants who received liquid fluoxetine 2-20 mg (of 4mg/1ml solution) in AM using a flexible dose strategy and planned 36 week titration schedule
Period Title: Overall Study
Started 10 8
Completed 4 4
Not Completed 6 4
Arm/Group Title Placebo Fluoxetine Total
Hide Arm/Group Description Participants will take the placebo Participants will take liquid fluoxetine 2-20 mg Total of all reporting groups
Overall Number of Baseline Participants 10 8 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 8 participants 18 participants
<=18 years
10
 100.0%
8
 100.0%
18
 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%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 10 participants 8 participants 18 participants
44.0  (6.6) 42.6  (8.1) 43.4  (7.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 8 participants 18 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
10
 100.0%
8
 100.0%
18
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 8 participants 18 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
  10.0%
1
  12.5%
2
  11.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  10.0%
2
  25.0%
3
  16.7%
White
7
  70.0%
5
  62.5%
12
  66.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
  10.0%
0
   0.0%
1
   5.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 8 participants 18 participants
10 8 18
1.Primary Outcome
Title Rate of Recruitment
Hide Description In order for a larger trial with similar design to be feasible a number of factors needed to be examined. The first was whether families would enroll very young children with ASD into a year long blinded medication study. To determine this we examined the average number of months to randomize 1 participant per site. We calculated this (as total # months required for recruitment* 2sites ) /[ # participants randomized ] and compared it to the typical # of months required to recruit an older child with ASD for a double-blind 12 week placebo controlled medication study, which is typically about 1.2 months at each of the sites involved in the study.
Time Frame 19 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Fluoxetine
Hide Arm/Group Description:
Participants will take the placebo
Participants will take liquid fluoxetine 2-20 mg
Overall Number of Participants Analyzed 10 8
Measure Type: Number
Unit of Measure: months/participant at 1 site
2.1 2.1
2.Secondary Outcome
Title Rate of Attrition
Hide Description The percentage of participants who discontinued treatment prior to completion of the 12 month study
Time Frame Measured at Month 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Fluoxetine
Hide Arm/Group Description:
participants who were treated with flexible dose placebo solution
Participants treated with flexible dose fluoxetine solution
Overall Number of Participants Analyzed 10 8
Measure Type: Number
Unit of Measure: percent of group that discontinued early
60 50
3.Secondary Outcome
Title Change From Baseline to 12 Months in Total Score on Caregiver Strain Questionnaire
Hide Description This is a caregiver completed measure that assesses the extent to which the caregiver feels care of the participant influences the caregiver's and other family members' emotional states and/or activities. There are a total of 22 items rated from 1 - not at all to 5 - very much (with one item reverse scored). Total score is the sum of all the items (with one item reverse scored). There are three subscales objective strain -12 items, internalized subjective strain 6 items, externalized subjective 4 items. The total score can range from a minimum of 0 - no strain at all, to 110 all items rated as very much.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Fluoxetine
Hide Arm/Group Description:
participants who were treated with flexible dose placebo solution
participants who were treated with flexible dose (2-20mg/D) fluoxetine solution
Overall Number of Participants Analyzed 10 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.8  (2.5) -1.86  (2.3)
4.Secondary Outcome
Title Change From Baseline to Month 12 in Aberrant Behavior Checklist Irritability Subscale Score (ABC-I)
Hide Description The Aberrant Behavior Checklist (ABC) is a caregiver completed rating scale that assesses problem behaviors frequently seen in individuals with developmental disabilities. There are a total of 58 items on 5 subscales that are rated from 0 - not at all a problem to 3 - problem is severe in degree. The ABC-I consists of 15 items that reflect mood swings, self-injury and aggression. The subscale score is the sum of the score on each of the 15 items. The minimum score on the ABC-I is 0 and the maximum score is 45. Higher scores reflect more severe behavioral problems. A score > or = to 18 is generally considered clinically significant.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Fluoxetine
Hide Arm/Group Description:
Participants will take the placebo
Participants will take liquid fluoxetine 2-20 mg
Overall Number of Participants Analyzed 10 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.70  (2.9) -8.50  (10.6)
Time Frame 12 months (The course of treatment for each participant in the trial)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Fluoxetine
Hide Arm/Group Description participants who were treated with flexible dose placebo solution participants who were treated with flexible dose fluoxetine solution, 2-20mg per day
All-Cause Mortality
Placebo Fluoxetine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Fluoxetine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/10 (10.00%)      0/8 (0.00%)    
Gastrointestinal disorders     
Severe Diarrhea  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Fluoxetine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/10 (90.00%)      7/8 (87.50%)    
Blood and lymphatic system disorders     
Nosebleed  1  2/10 (20.00%)  2 2/8 (25.00%)  2
bruise  1  0/10 (0.00%)  0 1/8 (12.50%)  1
Ear and labyrinth disorders     
Earache  1  3/10 (30.00%)  3 3/8 (37.50%)  3
Eye disorders     
other eye disorders  1  0/10 (0.00%)  0 3/8 (37.50%)  3
Gastrointestinal disorders     
gastroenteritis  1  6/10 (60.00%)  6 6/8 (75.00%)  6
General disorders     
Sensory Sensitivity  1  1/10 (10.00%)  1 1/8 (12.50%)  1
Sexual  1  0/10 (0.00%)  0 1/8 (12.50%)  1
insomnia  1  5/10 (50.00%)  5 5/8 (62.50%)  5
Immune system disorders     
allergies  1  3/10 (30.00%)  3 4/8 (50.00%)  4
Infections and infestations     
Cold/Flu/other systemic infection  1  7/10 (70.00%)  7 6/8 (75.00%)  6
Local Infection  1  1/10 (10.00%)  1 0/8 (0.00%)  0
Other infection  1  2/10 (20.00%)  2 1/8 (12.50%)  1
Injury, poisoning and procedural complications     
intentional injury  1  1/10 (10.00%)  1 1/8 (12.50%)  1
Metabolism and nutrition disorders     
weight increased  1  0/10 (0.00%)  0 2/8 (25.00%)  2
Nervous system disorders     
irritability  1  4/10 (40.00%)  4 3/8 (37.50%)  3
Psychiatric disorders     
aggression  1  4/10 (40.00%)  4 5/8 (62.50%)  5
mood lability  1  3/10 (30.00%)  3 0/8 (0.00%)  0
Renal and urinary disorders     
enuresis  1  2/10 (20.00%)  2 5/8 (62.50%)  5
Respiratory, thoracic and mediastinal disorders     
cough  1  3/10 (30.00%)  3 4/8 (50.00%)  4
Skin and subcutaneous tissue disorders     
rash  1  5/10 (50.00%)  5 2/8 (25.00%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.1)
It took twice as long to recruit subjects for a study in children 30-58 months than it generally takes to recruit older children. It is possible to maintain subjects in double-blind trails for extended periods.
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: Linmarie Sikich, MD
Organization: University of North Carolina
Phone: 919 966 8653
Responsible Party: Linmarie Sikich, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00183339     History of Changes
Other Study ID Numbers: U54MH066418 ( U.S. NIH Grant/Contract )
U54MH066418 ( U.S. NIH Grant/Contract )
First Submitted: September 6, 2005
First Posted: September 16, 2005
Results First Submitted: September 10, 2013
Results First Posted: March 26, 2014
Last Update Posted: March 26, 2014