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NCT00706654 · ClinicalTrials.gov registry record · Phase 3
Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia
A Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 3
- Development phase
- 937
- Enrollment target
NCT00706654: Completed Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT00706654 is a Phase 3 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 937 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (21% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00706654, a Phase 3 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 937 participants
- Enrollment target
Study Summary
The purpose of the this trial is to evaluate the efficacy, safety, and tolerability of an intramuscular (IM) depot formulation of aripiprazole as maintenance treatment in patients with schizophrenia The trial is designed into three treatment phases. Phase 1 is designed to allow for a subject to be converted from the current anti-psychotic treatment to oral non-generic aripiprazole monotherapy (oral conversion phase from 4 to 6 weeks). During Phase 2 the subject will be stabilized on oral non-generic aripiprazole monotherapy. Once the subject is stabilized in Phase 2 (oral stabilization phase from minimum 8 weeks to maximum 28 weeks), they are eligible to be randomized into the double-blind IM depot maintenance phase, Phase 3. During Phase 3, the subject will be assessed for exacerbation of psychotic symptoms and impending relapse for up to 38 weeks.
Primary Outcome
A patient had exacerbation of psychotic symptoms/impending relapse if they met any of the following 4 criteria. 1) Clinical Global Impression of Improvement score ≥ 5 and either an increase on any of the following Positive and Negative Syndrome Scale (PANSS) items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content) to a score \> 4 with an increase of ≥ 2 on that item since randomization or an increase on any of the same PANSS items to a score \> 4 and an
Interventions
- DRUG Placebo depot
- DRUG Placebo tablets
- DRUG Aripiprazole depot 300 or 400 mg
- DRUG Aripiprazole 10-30 mg orally
- DRUG Aripiprazole depot 25 or 50 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 937 participants |
| Start Date | 2008-09-01 |
| Est. Completion | 2012-08-01 |
| Phase | Phase 3 |
What the finished NCT00706654 record still lists
NCT00706654 is an interventional study that assigns participants to a tested intervention. The registered 937 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (21% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo depot is the first listed.
NCT00706654 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00706654 about?
NCT00706654 is a clinical study titled "Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia". The purpose of the this trial is to evaluate the efficacy, safety, and tolerability of an intramuscular (IM) depot formulation of aripiprazole as maintenance treatment in patients with schizophrenia The trial is designed into three treatment phases. Phase 1 is designed to allow for a subject to be ...
What is the current status of trial NCT00706654?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 937 participants. The study started on 2008-09-01. Estimated completion is 2012-08-01.
What interventions are being tested in trial NCT00706654?
The interventions under investigation include: Placebo depot (DRUG), Placebo tablets (DRUG), Aripiprazole depot 300 or 400 mg (DRUG), Aripiprazole 10-30 mg orally (DRUG), Aripiprazole depot 25 or 50 mg (DRUG).
Who is sponsoring clinical trial NCT00706654?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00706654's enrollment target sits among peer trials
937 338th of 2000 higher than 1,663 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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