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NCT00870727 · ClinicalTrials.gov registry record · Phase 3
Study of Aripiprazole in the Treatment of Pervasive Developmental Disorders
A Phase 3 study of Pervasive Developmental Disorder, sponsored by Indiana University.
- Completed
- Registry status
- Phase 3
- Development phase
- 33
- Enrollment target
- 1
- Study location
NCT00870727: Completed Phase 3 study of Pervasive Developmental Disorder, sponsored by Indiana University.
NCT00870727 is a Phase 3 study of Pervasive Developmental Disorder that has completed, run by Indiana University. The registered enrollment target is 33 participants, below the 76-participant average among 7 other Pervasive Developmental Disorder trials with a reported enrollment target (57% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00870727, a Phase 3 study of Pervasive Developmental Disorder, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 33 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to develop a better tolerated and more effective pharmacologic treatment with individuals with Pervasive Developmental Disorder. This is a double-blind, placebo-controlled study of aripiprazole in the management of the maladaptive behaviors of Pervasive Developmental Disorder. The investigators hypothesize that aripiprazole will be more effective than placebo for reducing aggression, tantrum and self-injurious behavior in children with Pervasive Developmental Disorder.
Primary Outcome
Clinical Global Impressions (Guy, 1976) global improvement (CGI-I) is designed to take into account all factors to arrive at an assessment of response to treatment. The CGI-I scale ranges from 1 to 7, with lower scores indicating greater improvement (1=very much improved and 2=much improved). Participants with a CGI-I score of 1 or 2 were classified as improved. Four participants assigned to placebo completed an exit interview prior to week 8. One participant assigned to placebo and one particip
Conditions Studied
Interventions
- DRUG Placebo oral capsule
- DRUG Aripiprazole oral product
Study Locations (1)
Indiana
- Riley Hospital for Children, Christian Sarkine Autism Treatment Center - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2009-02 |
| Est. Completion | 2015-05 |
| Phase | Phase 3 |
What the finished NCT00870727 record still lists
NCT00870727 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 76-participant average among 7 other Pervasive Developmental Disorder trials with a reported enrollment target (57% lower).
The record links to 1 condition, with Pervasive Developmental Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo oral capsule is the first listed.
NCT00870727 reports a single indexed study location in Indiana.
Frequently Asked Questions
What is clinical trial NCT00870727 about?
NCT00870727 is a clinical study titled "Study of Aripiprazole in the Treatment of Pervasive Developmental Disorders". The purpose of this study is to develop a better tolerated and more effective pharmacologic treatment with individuals with Pervasive Developmental Disorder. This is a double-blind, placebo-controlled study of aripiprazole in the management of the maladaptive behaviors of Pervasive Developmental Dis...
What is the current status of trial NCT00870727?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 33 participants. The study started on 2009-02. Estimated completion is 2015-05.
What conditions does trial NCT00870727 study?
This clinical trial studies the following conditions: Pervasive Developmental Disorder.
What interventions are being tested in trial NCT00870727?
The interventions under investigation include: Placebo oral capsule (DRUG), Aripiprazole oral product (DRUG).
Who is sponsoring clinical trial NCT00870727?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00870727 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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