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NCT00308074 · ClinicalTrials.gov registry record · Phase 2
An Open-Label Trial of Aripiprazole in Autism Spectrum Disorders
A Phase 2 study of Autism and Pervasive Developmental Disorder, sponsored by Cambridge Health Alliance.
- Completed
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
- 1
- Study location
NCT00308074: Completed Phase 2 study of Autism and Pervasive Developmental Disorder, sponsored by Cambridge Health Alliance.
NCT00308074 is a Phase 2 study of Autism and Pervasive Developmental Disorder that has completed, run by Cambridge Health Alliance. The registered enrollment target is 14 participants, below the 183-participant average among 104 other Autism trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00308074, a Phase 2 study of Autism and Pervasive Developmental Disorder, has completed, sponsored by Cambridge Health Alliance.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
- 1
- Study location
Study Summary
The aim of this study is to evaluate the efficacy, safety and tolerability of aripiprazole monotherapy in the treatment of children and adolescents suffering from Autism Spectrum Disorder (ASD) over a 12-week period. We hypothesize that aripiprazole may be helpful in reducing ASD-associated symptoms of anxiety and aggression, resulting in significant improvements in global outcome.
Primary Outcome
The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to evaluate how much the patient's illness has improved or worsened compared to their baseline condition at the beginning of the intervention. The ratings are evaluated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.
Conditions Studied
Interventions
- DRUG Aripiprazole
Study Locations (1)
Massachusetts
- Cambridge Health Alliance - Medford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2006-02 |
| Est. Completion | 2009-02 |
| Phase | Phase 2 |
What the finished NCT00308074 record still lists
NCT00308074 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 183-participant average among 104 other Autism trials with a reported enrollment target (92% lower).
The record links to 3 conditions, with Autism appearing as the primary indexed condition, and to 1 intervention - of which Aripiprazole is the first listed.
NCT00308074 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00308074 about?
NCT00308074 is a clinical study titled "An Open-Label Trial of Aripiprazole in Autism Spectrum Disorders". The aim of this study is to evaluate the efficacy, safety and tolerability of aripiprazole monotherapy in the treatment of children and adolescents suffering from Autism Spectrum Disorder (ASD) over a 12-week period. We hypothesize that aripiprazole may be helpful in reducing ASD-associated symptoms...
What is the current status of trial NCT00308074?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2006-02. Estimated completion is 2009-02.
What conditions does trial NCT00308074 study?
This clinical trial studies the following conditions: Autism, Pervasive Developmental Disorder, Asperger's Disorder.
What interventions are being tested in trial NCT00308074?
The interventions under investigation include: Aripiprazole (DRUG).
Who is sponsoring clinical trial NCT00308074?
This trial is sponsored by Cambridge Health Alliance, which has 45 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00308074 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Autism
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00308074's enrollment target sits among peer trials
14 97th of 104 higher than 7 of 104 other Autism trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Autism 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.
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