ClinicalTrials.gov
ClinicalTrials.gov Menu

Guanfacine for the Treatment of Hyperactivity in Pervasive Developmental Disorder

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: NCT01238575
Recruitment Status : Completed
First Posted : November 10, 2010
Results First Posted : December 7, 2015
Last Update Posted : December 7, 2015
Sponsor:
Collaborators:
Emory University
Massachusetts General Hospital
Seattle Children's Hospital
University of California, Los Angeles
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Yale University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Pervasive Development Disorders
Interventions Other: placebo
Drug: extended-release guanfacine
Enrollment 62
Recruitment Details  
Pre-assignment Details 81 total patients screened. 13 ineligible. 6 Declined
Arm/Group Title Extended-release Guanfacine Inactive Placebo
Hide Arm/Group Description extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks placebo: Administered for up to 8 weeks.
Period Title: Overall Study
Started 30 32
Completed 26 28
Not Completed 4 4
Reason Not Completed
Lack of Efficacy             2             4
Adverse Event             2             0
Arm/Group Title Extended-release Guanfacine Inactive Placebo Total
Hide Arm/Group Description extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks placebo: Administered for up to 8 weeks. Total of all reporting groups
Overall Number of Baseline Participants 30 32 62
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 32 participants 62 participants
8.44  (2.28) 8.39  (2.23) 8.4  (2.25)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 32 participants 62 participants
Female
4
  13.3%
5
  15.6%
9
  14.5%
Male
26
  86.7%
27
  84.4%
53
  85.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 32 participants 62 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
4
  13.3%
1
   3.1%
5
   8.1%
Native Hawaiian or Other Pacific Islander
1
   3.3%
1
   3.1%
2
   3.2%
Black or African American
7
  23.3%
4
  12.5%
11
  17.7%
White
17
  56.7%
23
  71.9%
40
  64.5%
More than one race
1
   3.3%
3
   9.4%
4
   6.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Aberrant Behavior Checklist Hyperactivity Subscale
Hide Description The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. The 16-item Hyperactivity subscale covers over-activity (7 items), impulsiveness (2 items), inattention (3 items) and noncompliance (4 items). It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. The range of scores is 0 to 48.
Time Frame Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Extended-release Guanfacine Inactive Placebo
Hide Arm/Group Description:
extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
placebo: Administered for up to 8 weeks.
Overall Number of Participants Analyzed 30 32
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
19.3
(15.33 to 23.33)
29.7
(25.82 to 33.53)
2.Secondary Outcome
Title ADHD Rating Scale - Total
Hide Description The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. The total score can range from 0 to 54, with a higher score indicating greater severity.
Time Frame Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Extended-release Guanfacine Inactive Placebo
Hide Arm/Group Description:
extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
placebo: Administered for up to 8 weeks.
Overall Number of Participants Analyzed 30 32
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
25.2
(21.44 to 29.03)
38.0
(34.44 to 41.63)
3.Secondary Outcome
Title Aberrant Behavior Checklist Irritability Subscale
Hide Description The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. It is a 58 item checklist which takes about 10 – 15 minutes to complete. There are five subscales: a) Irritability and Agitation b) Lethargy and Social Withdrawal c) Stereotypic Behavior d) Hyperactivity and Noncompliance and e) Inappropriate Speech. The higher the number of items (score), the greater the amount of symptoms. Scores can range from 0 to 45.
Time Frame 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Extended-release Guanfacine Inactive Placebo
Hide Arm/Group Description:
extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
placebo: Administered for up to 8 weeks.
Overall Number of Participants Analyzed 30 32
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
13.5
(10.01 to 17.06)
16.1
(12.68 to 19.54)
4.Secondary Outcome
Title Aberrant Behavior Checklist Social Withdrawal Subscale
Hide Description The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. This subscale's scores can range from 0 to 48.
Time Frame 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Extended-release Guanfacine Inactive Placebo
Hide Arm/Group Description:
extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
placebo: Administered for up to 8 weeks.
Overall Number of Participants Analyzed 30 32
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
9.8
(7.26 to 12.27)
8.6
(6.10 to 11.02)
5.Secondary Outcome
Title Aberrant Behavior Checklist Sterotypy Subscale
Hide Description The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. This subscale's scores can range from 0 to 21.
Time Frame 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Extended-release Guanfacine Inactive Placebo
Hide Arm/Group Description:
extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
placebo: Administered for up to 8 weeks.
Overall Number of Participants Analyzed 30 32
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
3.6
(2.03 to 5.26)
5.9
(4.37 to 7.49)
6.Secondary Outcome
Title Aberrant Behavior Checklist Inappropriate Speech Subscale
Hide Description The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. This subscale's scores can range from 0 to 12.
Time Frame 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Extended-release Guanfacine Inactive Placebo
Hide Arm/Group Description:
extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
placebo: Administered for up to 8 weeks.
Overall Number of Participants Analyzed 30 32
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
4.2
(3.24 to 5.26)
5.99
(4.5 to 6.97)
7.Secondary Outcome
Title ADHD Rating Scale - Inattention Subscale
Hide Description The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. This subscale can range from 0 to 27 for scoring, with a higher score indicating greater severity.
Time Frame 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Extended-release Guanfacine Inactive Placebo
Hide Arm/Group Description:
extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
placebo: Administered for up to 8 weeks.
Overall Number of Participants Analyzed 30 32
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
14.7
(12.55 to 16.78)
19.5
(17.52 to 21.56)
8.Secondary Outcome
Title ADHD Rating Scale - Hyperactivity Subscale
Hide Description The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. This subscale can range from 0 to 27 for scoring,with a higher score indicating greater severity.
Time Frame 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Extended-release Guanfacine Inactive Placebo
Hide Arm/Group Description:
extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
placebo: Administered for up to 8 weeks.
Overall Number of Participants Analyzed 30 32
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
10.6
(8.5 to 12.75)
18.7
(16.66 to 20.69)
9.Secondary Outcome
Title Aberrant Behavior Checklist Hyperactivity Subscale
Hide Description

The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech.

The 16-item Hyperactivity subscale covers over-activity (7 items), impulsiveness (2 items), inattention (3 items) and noncompliance (4 items). It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. The range of scores is 0 to 48.

Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Extended-release Guanfacine Inactive Placebo
Hide Arm/Group Description:
extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
placebo: Administered for up to 8 weeks.
Overall Number of Participants Analyzed 30 32
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
34.4
(32.4 to 36.4)
34.25
(31.74 to 36.76)
10.Secondary Outcome
Title Aberrant Behavior Checklist Irritability Subscale
Hide Description The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. Scores for this subscale can range from 0 to 45.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Extended-release Guanfacine Inactive Placebo
Hide Arm/Group Description:
extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
placebo: Administered for up to 8 weeks.
Overall Number of Participants Analyzed 30 32
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
20.3
(16.79 to 23.81)
18.06
(14.54 to 21.58)
11.Secondary Outcome
Title Aberrant Behavior Checklist Social Withdrawal Subscale
Hide Description The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. This subscale's scores can range from 0 to 48.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Extended-release Guanfacine Inactive Placebo
Hide Arm/Group Description:
extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
placebo: Administered for up to 8 weeks.
Overall Number of Participants Analyzed 30 32
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
13.6
(10.08 to 17.12)
12.06
(8.71 to 15.41)
12.Secondary Outcome
Title Aberrant Behavior Checklist Sterotypy Subscale
Hide Description The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. This subscale's scores can range from 0 to 21.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Extended-release Guanfacine Inactive Placebo
Hide Arm/Group Description:
extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
placebo: Administered for up to 8 weeks.
Overall Number of Participants Analyzed 30 32
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
8.53
(6.41 to 10.66)
9.31
(7.31 to 11.32)
13.Secondary Outcome
Title Aberrant Behavior Checklist Inappropriate Speech Subscale
Hide Description The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. This subscale's scores can range from 0 to 12.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Extended-release Guanfacine Inactive Placebo
Hide Arm/Group Description:
extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
placebo: Administered for up to 8 weeks.
Overall Number of Participants Analyzed 30 32
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
6.33
(5.02 to 7.65)
6.84
(5.63 to 8.06)
14.Secondary Outcome
Title ADHD Rating Scale - Inattention Subscale
Hide Description The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. This subscale can range from 0 to 27 for scoring, with a higher score indicating greater severity.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Extended-release Guanfacine Inactive Placebo
Hide Arm/Group Description:
extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
placebo: Administered for up to 8 weeks.
Overall Number of Participants Analyzed 30 32
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
20.53
(19.17 to 21.9)
20.41
(18.75 to 22.06)
15.Secondary Outcome
Title ADHD Rating Scale - Hyperactivity Subscale
Hide Description The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. This subscale can range from 0 to 27 for scoring, with a higher score indicating greater severity.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Extended-release Guanfacine Inactive Placebo
Hide Arm/Group Description:
extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
placebo: Administered for up to 8 weeks.
Overall Number of Participants Analyzed 30 32
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
19.00
(17.38 to 20.62)
19.5
(17.71 to 21.29)
16.Secondary Outcome
Title ADHD Rating Scale - Total
Hide Description The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. The total score can range from 0 to 54, with a higher score indicating greater severity.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Extended-release Guanfacine Inactive Placebo
Hide Arm/Group Description:
extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
placebo: Administered for up to 8 weeks.
Overall Number of Participants Analyzed 30 32
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
39.53
(37.33 to 41.73)
39.91
(37.5 to 42.32)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Extended-release Guanfacine Inactive Placebo
Hide Arm/Group Description extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks placebo: Administered for up to 8 weeks.
All-Cause Mortality
Extended-release Guanfacine Inactive Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Extended-release Guanfacine Inactive Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/30 (3.33%)   0/32 (0.00%) 
Psychiatric disorders     
Aggressive [1]  1/30 (3.33%)  0/32 (0.00%) 
[1]
Subject became verbally and physically agressive
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Extended-release Guanfacine Inactive Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   30/30 (100.00%)   25/32 (78.13%) 
Eye disorders     
Blurred Vision  2/30 (6.67%)  0/32 (0.00%) 
Gastrointestinal disorders     
Dry Mouth  12/30 (40.00%)  1/32 (3.13%) 
Stomachache  8/30 (26.67%)  4/32 (12.50%) 
Constipation  7/30 (23.33%)  2/32 (6.25%) 
Nausea  3/30 (10.00%)  2/32 (6.25%) 
Diarrhea  3/30 (10.00%)  0/32 (0.00%) 
Vomiting  3/30 (10.00%)  3/32 (9.38%) 
Increased Appetite  2/30 (6.67%)  2/32 (6.25%) 
General disorders     
Fatigue  19/30 (63.33%)  3/32 (9.38%) 
Decreased Appetite  13/30 (43.33%)  2/32 (6.25%) 
Emotional/tearful  12/30 (40.00%)  3/32 (9.38%) 
Irritability  11/30 (36.67%)  3/32 (9.38%) 
Increased Energy  9/30 (30.00%)  6/32 (18.75%) 
Weakness  3/30 (10.00%)  1/32 (3.13%) 
Fever  1/30 (3.33%)  3/32 (9.38%) 
Nervous system disorders     
Drowsiness  26/30 (86.67%)  3/32 (9.38%) 
Headache  9/30 (30.00%)  6/32 (18.75%) 
Dizziness  3/30 (10.00%)  2/32 (6.25%) 
Motor Tics  1/30 (3.33%)  2/32 (6.25%) 
Psychiatric disorders     
Anxiety  9/30 (30.00%)  1/32 (3.13%) 
Mid sleep awakening  9/30 (30.00%)  2/32 (6.25%) 
Increased Repetitive Behavior  5/30 (16.67%)  3/32 (9.38%) 
Aggression  5/30 (16.67%)  2/32 (6.25%) 
Depressed Mood  4/30 (13.33%)  1/32 (3.13%) 
Self-injury  3/30 (10.00%)  0/32 (0.00%) 
Trouble Falling Asleep  3/30 (10.00%)  2/32 (6.25%) 
Silly  3/30 (10.00%)  5/32 (15.63%) 
Excessive Talking  2/30 (6.67%)  9/32 (28.13%) 
Nightmares  2/30 (6.67%)  0/32 (0.00%) 
Renal and urinary disorders     
Enuresis  2/30 (6.67%)  2/32 (6.25%) 
Respiratory, thoracic and mediastinal disorders     
Cough/Congestion  4/30 (13.33%)  4/32 (12.50%) 
Skin and subcutaneous tissue disorders     
Skin rash/Eczema  2/30 (6.67%)  4/32 (12.50%) 
Skin Picking  1/30 (3.33%)  3/32 (9.38%) 
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: Lawrence Scahill, MSN, PhD
Organization: Emory University
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01238575     History of Changes
Other Study ID Numbers: R01MH083707 ( U.S. NIH Grant/Contract )
R01MH083707 ( U.S. NIH Grant/Contract )
First Submitted: October 29, 2010
First Posted: November 10, 2010
Results First Submitted: April 30, 2015
Results First Posted: December 7, 2015
Last Update Posted: December 7, 2015