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NCT00194012 · ClinicalTrials.gov registry record · Phase 3
Study of Aripiprazole (Abilify) Versus Placebo in Children With Subsyndromal Bipolar Disorder
A Phase 3 study, sponsored by University Hospitals Cleveland Medical Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 62
- Enrollment target
NCT00194012: Completed Phase 3 study, sponsored by University Hospitals Cleveland Medical Center.
NCT00194012 is a Phase 3 study that has completed, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 62 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00194012, a Phase 3 study, has completed, sponsored by University Hospitals Cleveland Medical Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 62 participants
- Enrollment target
Study Summary
The purpose of this study is to test the effectiveness and tolerability/safety of aripiprazole (Abilify) in children with subsyndromal symptoms of bipolar disorder who also have a parent with bipolar disorder and other family member with a mood disorder.
Primary Outcome
The Young Mania Rating Scale (YMRS) has 11 items and is based on the patient's subjective report of his or her clinical condition over the previous 48 hours. Additional information is based upon clinical observations made during the course of the clinical interview. The items are selected based upon published descriptions of the core symptoms of mania. Each item o the YMRS is given a severity rating. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, a
Interventions
- DRUG Placebo
- DRUG Aripiprazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2004-08 |
| Est. Completion | 2012-06 |
| Phase | Phase 3 |
What the finished NCT00194012 record still lists
NCT00194012 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00194012 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00194012 about?
NCT00194012 is a clinical study titled "Study of Aripiprazole (Abilify) Versus Placebo in Children With Subsyndromal Bipolar Disorder". The purpose of this study is to test the effectiveness and tolerability/safety of aripiprazole (Abilify) in children with subsyndromal symptoms of bipolar disorder who also have a parent with bipolar disorder and other family member with a mood disorder.
What is the current status of trial NCT00194012?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 62 participants. The study started on 2004-08. Estimated completion is 2012-06.
What interventions are being tested in trial NCT00194012?
The interventions under investigation include: Placebo (DRUG), Aripiprazole (DRUG).
Who is sponsoring clinical trial NCT00194012?
This trial is sponsored by University Hospitals Cleveland Medical Center, which has 230 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00194012's enrollment target sits among peer trials
62 1802nd of 2000 higher than 198 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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