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NCT00194077 · ClinicalTrials.gov registry record · Phase 3

Study of Aripiprazole (Abilify) in Children With Symptoms of Mania

A Phase 3 study of Bipolar Disorder, sponsored by University Hospitals Cleveland Medical Center.

Completed
Registry status
Phase 3
Development phase
60
Enrollment target
1
Study location

NCT00194077: Completed Phase 3 study of Bipolar Disorder, sponsored by University Hospitals Cleveland Medical Center.

NCT00194077 is a Phase 3 study of Bipolar Disorder that has completed, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 60 participants, below the 332-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00194077, a Phase 3 study of Bipolar Disorder, has completed, sponsored by University Hospitals Cleveland Medical Center.

COMPLETED
Registry status
Phase 3
Development phase
60 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to look at the safety and effectiveness of aripiprazole (abilify) in children with bipolar disorder and to examine whether or not patients that respond to initial mood stabilization benefit from continued pharmacotherapy.

Primary Outcome

Time in weeks to discontinuation due to any reason, including mood event, adverse event, or other.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Aripiprazole

Study Locations (1)

Ohio

  • University Hospitals Case Medical Center - Cleveland

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2004-08
Est. Completion 2011-01
Phase Phase 3

What the finished NCT00194077 record still lists

NCT00194077 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 332-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (82% lower).

The record links to 1 condition, with Bipolar Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT00194077 reports a single indexed study location in Ohio.

Frequently Asked Questions

What is clinical trial NCT00194077 about?

NCT00194077 is a clinical study titled "Study of Aripiprazole (Abilify) in Children With Symptoms of Mania". The purpose of this study is to look at the safety and effectiveness of aripiprazole (abilify) in children with bipolar disorder and to examine whether or not patients that respond to initial mood stabilization benefit from continued pharmacotherapy.

What is the current status of trial NCT00194077?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 60 participants. The study started on 2004-08. Estimated completion is 2011-01.

What conditions does trial NCT00194077 study?

This clinical trial studies the following conditions: Bipolar Disorder.

What interventions are being tested in trial NCT00194077?

The interventions under investigation include: Placebo (DRUG), Aripiprazole (DRUG).

Who is sponsoring clinical trial NCT00194077?

This trial is sponsored by University Hospitals Cleveland Medical Center, which has 230 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00194077 being conducted?

This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Bipolar Disorder

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 NCT00194077's enrollment target sits among peer trials

60 88th of 162 higher than 68 of 162 other Bipolar Disorder trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Bipolar Disorder 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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Source: ClinicalTrials.gov NCT00194077, the US trial registry maintained by the National Library of Medicine. NCT00194077 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.