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Trial record 37 of 87 for:    Asperger Syndrome

Effectiveness of Atomoxetine in Treating ADHD Symptoms in Children and Adolescents With Autism

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: NCT00498173
Recruitment Status : Completed
First Posted : July 9, 2007
Results First Posted : August 14, 2017
Last Update Posted : August 14, 2017
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Christopher John McDougle, M.D., Massachusetts General Hospital

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Sequential Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Autism
Interventions: Drug: Atomoxetine
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Atomoxetine

Participants will receive flexibly dosed atomoxetine for 8 weeks. Dosage can be increased over the first 4 weeks of study participation and will then be held constant for the remainder of the 8-week trial.

Atomoxetine: Available tablet strengths of atomoxetine: 5 mg, 10 mg, 25 mg, 40 mg. Week 1 participant takes 0.5 mg/kg/day, Week 2: 0.8 mg/kg/day, Week 3: 1.2 mg/kg/day. Potential exists for dose increase at Week 4 to 1.8 mg/kg/day based on clinical global impression-improvement rating at Week 4.

Placebo

Participants will receive blinded, matched placebo for 8 weeks. Dosage can be increased over the first 4 weeks of study participation and will then be held constant for the remainder of the 8-week trial.

Placebo: Placebo tablets dosages: 5 mg, 10 mg, 25 mg, 40 mg.

Atomoxetine (Open Label Trial) Placebo-treated subjects from the randomized trial that don't respond to placebo will be offered an 8-week open-label trial of atomoxetine.

Participant Flow for 2 periods

Period 1:   Phase 1-Blinded Randomization (8 Weeks)
    Atomoxetine   Placebo   Atomoxetine (Open Label Trial)
STARTED   29   31   0 
COMPLETED   27   30   0 
NOT COMPLETED   2   1   0 
no post-baseline ratings                2                1                0 

Period 2:   Phase 2-Atomoxetine Open Label (8 Weeks)
    Atomoxetine   Placebo   Atomoxetine (Open Label Trial)
STARTED   0   0   26 
COMPLETED   0   0   26 
NOT COMPLETED   0   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Atomoxetine

Participants will receive flexibly dosed atomoxetine for 8 weeks. Dosage can be increased over the first 4 weeks of study participation and will then be held constant for the remainder of the 8-week trial.

Atomoxetine: Available tablet strengths of atomoxetine: 5 mg, 10 mg, 25 mg, 40 mg. Week 1 participant takes 0.5 mg/kg/day, Week 2: 0.8 mg/kg/day, Week 3: 1.2 mg/kg/day. Potential exists for dose increase at Week 4 to 1.8 mg/kg/day based on clinical global impression-improvement rating at Week 4.

Placebo

Participants will receive blinded, matched placebo for 8 weeks. Dosage can be increased over the first 4 weeks of study participation and will then be held constant for the remainder of the 8-week trial.

Placebo: Placebo tablets dosages: 5 mg, 10 mg, 25 mg, 40 mg.

Total Total of all reporting groups

Baseline Measures
   Atomoxetine   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 29   31   60 
Age 
[Units: Years]
Mean (Standard Deviation)
     
Participants Analyzed   29   31   60 
   9.3  (2.6)   8.4  (2.1)   8.8  (2.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Participants Analyzed   29   31   60 
Female      3  10.3%      3   9.7%      6  10.0% 
Male      26  89.7%      28  90.3%      54  90.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Participants Analyzed   29   31   60 
Hispanic or Latino      2   6.9%      2   6.5%      4   6.7% 
Not Hispanic or Latino      26  89.7%      28  90.3%      54  90.0% 
Unknown or Not Reported      1   3.4%      1   3.2%      2   3.3% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Participants Analyzed   29   31   60 
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      5  17.2%      0   0.0%      5   8.3% 
White      22  75.9%      30  96.8%      52  86.7% 
More than one race      0   0.0%      1   3.2%      1   1.7% 
Unknown or Not Reported      2   6.9%      0   0.0%      2   3.3% 
Region of Enrollment 
[Units: Participants]
     
United States       
Participants Analyzed   29   31   60 
United States   29   31   60 
Attending Public School [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed   29   31   60 
   24   27   51 
[1] All children attended school. Children not attending public school attended private, specialized, or home school, or a specialized classroom with type of school unspecified.
Indiana University School of Medicine Site 
[Units: Participants]
Count of Participants
     
Participants Analyzed   29   31   60 
   25   27   52 
Tanner Stage 3 or Greater [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed   29   31   60 
   3   1   4 
[1] Tanner stage (1-5) was used to characterize physical development in children, adolescents, and to stratify randomization.The stage was based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage increases as the child develops. Randomization lists for each of the four strata defined by pubertal status (prepubertal [Tanner Stage I or 2] vs. postpubertal [Tanner Stage 3-5]) and gender (male vs. female) were utilized.
DSM-IV Diagnosis 
[Units: Participants]
Count of Participants
     
Autistic Disorder       
Participants Analyzed   29   31   60 
Autistic Disorder   14   9   23 
Asperger's Disorder       
Participants Analyzed   29   31   60 
Asperger's Disorder   5   9   14 
Pervasive Developmental Disorder (PDD-NOS)       
Participants Analyzed   29   31   60 
Pervasive Developmental Disorder (PDD-NOS)   10   13   23 
Concomitant Medication Use 
[Units: Participants]
Count of Participants
     
Participants Analyzed   29   31   60 
   22   20   42 
IQ [1] [2] 
[Units: Units on a scale]
Mean (Standard Deviation)
     
Participants Analyzed   27   30   57 
   74.7  (18.5)   84.4  (15.2)   79.8  (17.4) 
[1] IQ was estimated from the Mullen Scale for 1 child assigned to atomoxetine and the Stanford Binet test for all other children.
[2] IQ scores were not obtained for 2 children assigned to atomoxetine and 1 child assigned to placebo.
Clinical Global Impression-Severity 
[Units: Participants]
Count of Participants
     
Moderate       
Participants Analyzed   29   31   60 
Moderate   16   17   33 
Marked       
Participants Analyzed   29   31   60 
Marked   13   12   25 
Severe       
Participants Analyzed   29   31   60 
Severe   0   2   2 
Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale Total [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
     
Participants Analyzed   29   31   60 
   37.2  (7.6)   41.5  (5.8)   39.4  (7.0) 
[1] 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 scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). The total score can range from 0 to 54, with a higher score indicating greater severity.
Aberrant Behavior Checklist, Hyperactivity 
[Units: Units on a scale]
Mean (Standard Deviation)
     
Participants Analyzed   29   31   60 
   29.1  (11.8)   31.7  (10.0)   30.5  (10.9) 
Social Responsiveness Scale 
[Units: Units on a scale]
Mean (Standard Deviation)
     
Participants Analyzed   29   31   60 
   84.5  (9.9)   84.4  (10.3)   84.5  (10.0) 
Vineland Adaptive Behavior Composite Score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
     
Participants Analyzed   29   31   60 
   73.1  (12.5)   72.5  (8.7)   72.8  (10.6) 
[1] The Vineland Adaptive Behavior Scales, Second Edition is a measure of adaptive behavior in children, adolescents and adults. The composite score has a mean of 100 and a standard deviation of 15 (range = 20 to 160). Higher scores suggest a higher level of adaptive functioning. A rise in standard scores from Baseline to the Final Visit indicates improvement.
Pediatric Quality of Life Inventory Health Related Functioning [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
     
Participants Analyzed   29   31   60 
   56.3  (18.8)   60.5  (19.6)   58.5  (19.2) 
[1] Scores range from 0–100, with higher scores indicating better quality of life.
Pediatric Quality of Life Inventory Family Functioning [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
     
Participants Analyzed   29   31   60 
   52.4  (24.2)   53.1  (23.4)   52.7  (23.6) 
[1] Scores range from 0–100, with higher scores representing better family functioning.
Pediatric Anxiety Rating Scale, 5-Item Total [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
     
Participants Analyzed   29   31   60 
   8.5  (6.5)   8.9  (6.0)   8.7  (6.2) 
[1] Scaled score ranges form 0-25 with higher scores indicating more severe anxiety symptoms.


  Outcome Measures

1.  Primary:   ADHD Rating Scale (ADHDRS)-Home Version Total Score (Randomized Phase)   [ Time Frame: 8 weeks ]

2.  Secondary:   ADHD Rating Scale (ADHDRS)-Home Version Inattention and Hyperactivity Scores (Randomized Phase)   [ Time Frame: 8 weeks ]

3.  Secondary:   Aberrant Behavior Checklist (ABC) (Randomized Phase)   [ Time Frame: 8 weeks ]

4.  Secondary:   Social Responsiveness Scale (SRS) (Randomized Phase)   [ Time Frame: 8 weeks ]

5.  Secondary:   Vineland Adaptive Behavior Scales (VABS) Composite Score (Randomized Phase)   [ Time Frame: 8 weeks ]

6.  Secondary:   Pediatric Quality of Life Inventory (Randomized Phase)   [ Time Frame: 8 weeks ]

7.  Secondary:   Pediatric Anxiety Rating Scale, 5-Item Total (Randomized Phase)   [ Time Frame: 8 weeks ]

8.  Secondary:   Odds of Clinical Global Impression-Improvement Scale, Very Much or Much Improved (1 or 2) (Randomized Phase)   [ Time Frame: 8 weeks ]

9.  Secondary:   Change in ADHD Rating Scale (ADHDRS)-Home Version Total Score (Open-label Trial)   [ Time Frame: 8 weeks ]

10.  Secondary:   Change in ADHD Rating Scale (ADHDRS)-Home Version Inattention and Hyperactivity Scores (Open-label Trial)   [ Time Frame: 8 weeks ]

11.  Secondary:   Change in Aberrant Behavior Checklist (ABC) (Open-label Trial)   [ Time Frame: 8 weeks ]

12.  Secondary:   Change in Social Responsiveness Scale (SRS) (Open-label Trial)   [ Time Frame: 8 weeks ]

13.  Secondary:   Change in Vineland Adaptive Behavior Scales (VABS) Composite Score (Open-label Trial)   [ Time Frame: 8 weeks ]

14.  Secondary:   Change in Pediatric Quality of Life Inventory (Open-label Trial)   [ Time Frame: 8 weeks ]

15.  Secondary:   Change in Pediatric Anxiety Rating Scale, 5-item Total (Open-label Trial)   [ Time Frame: 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Christopher John McDougle, M.D.
Organization: Lurie Center for Autism, Massachusetts General Hospital
phone: 7818601721
e-mail: cmcdougle@mgh.harvard.edu



Responsible Party: Christopher John McDougle, M.D., Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00498173     History of Changes
Other Study ID Numbers: R01MH077600 ( U.S. NIH Grant/Contract )
R01MH077600 ( U.S. NIH Grant/Contract )
DDTR B2-NDA ( Other Identifier )
First Submitted: July 6, 2007
First Posted: July 9, 2007
Results First Submitted: March 17, 2017
Results First Posted: August 14, 2017
Last Update Posted: August 14, 2017