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NCT00844753 · ClinicalTrials.gov registry record · Phase 4
Atomoxetine, Placebo and Parent Management Training in Autism
A Phase 4 study, sponsored by University of Rochester.
- Completed
- Registry status
- Phase 4
- Development phase
- 128
- Enrollment target
NCT00844753: Completed Phase 4 study, sponsored by University of Rochester.
NCT00844753 is a Phase 4 study that has completed, run by University of Rochester. The registered enrollment target is 128 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00844753, a Phase 4 study, has completed, sponsored by University of Rochester.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 128 participants
- Enrollment target
Study Summary
The study will evaluate the effectiveness of atomoxetine (Strattera) with and without Parent Management Training (PMT) in children with Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDDNOS) who have symptoms of Attention Deficit Hyperactivity Disorder (ADHD). This is a double-blind placebo, parallel study where the atomoxetine will have a dose titration over a 6 week period. All children will be seen weekly during this titration period, with additional visits at Week 8 and Week 10. Families assigned to the PMT arm will have an additional weekly meeting with a clinician for a total of 9 PMT visits. PMT involves teaching parents to implement behavioral interventions with their children. Subjects who are clinical responders (ADHD Responders and Compliance Responders) from the 10 week study period will be followed every 4 weeks in a 24-week extension study. Subjects who are clinical nonresponders will continue in PMT if they received PMT during the double-blind phase, and they will receive an open trial of atomoxetine if they were on placebo during the double-blind phase. All subjects (responders and nonresponders) will be invited to participate in follow-up assessments every 4 weeks for 24 weeks after the completion of the double-blind phase.
Primary Outcome
Respondents were defined as having ≥30% decrease on the SNAP and CGI-I\<=2). The Swanson, Nolan, and Pelham (SNAP)-IV Parent and Teacher Rating Scales were used to measure ADHD and oppositional symptoms at home and school. The SNAP-IV ADHD section contains items for each of the 18 Diagnostic and Statistical Manual of Mental Disorders-IV symptoms of ADHD rated from 0 (not at all) to 3 (very much). The Clinical Global Impressions Scale (CGI) includes subscales for severity of illness and global im
Interventions
- DRUG Placebo
- BEHAVIORAL Parent Management Training
- DRUG atomoxetine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2008-10 |
| Est. Completion | 2014-04 |
| Phase | Phase 4 |
What the finished NCT00844753 record still lists
NCT00844753 is an interventional study that assigns participants to a tested intervention. The registered 128 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00844753 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00844753 about?
NCT00844753 is a clinical study titled "Atomoxetine, Placebo and Parent Management Training in Autism". The study will evaluate the effectiveness of atomoxetine (Strattera) with and without Parent Management Training (PMT) in children with Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDDNOS) who have symptoms of Attention Deficit Hyperactivity Disorder (ADH...
What is the current status of trial NCT00844753?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 128 participants. The study started on 2008-10. Estimated completion is 2014-04.
What interventions are being tested in trial NCT00844753?
The interventions under investigation include: Placebo (DRUG), Parent Management Training (BEHAVIORAL), atomoxetine (DRUG).
Who is sponsoring clinical trial NCT00844753?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00844753's enrollment target sits among peer trials
128 634th of 2000 higher than 1,362 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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