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NCT01396421 · ClinicalTrials.gov registry record · Phase 3
Study of the Effectiveness of Three Different Doses of OPC-34712 in the Treatment of Adults With Acute Schizophrenia
A Phase 3 study of Acute Schizophrenia, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 3
- Development phase
- 636
- Enrollment target
- 20
- Study locations
NCT01396421: Completed Phase 3 study of Acute Schizophrenia, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT01396421 is a Phase 3 study of Acute Schizophrenia that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 636 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (18% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01396421, a Phase 3 study of Acute Schizophrenia, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 636 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to compare the effectiveness, safety and tolerability of three different doses of OPC-34712 with placebo in the treatment of acute schizophrenia in adults.
Primary Outcome
The PANSS consists of 3 subscales (positive subscale, negative subscale and general psychology subscale) containing a total of 30 symptom constructs and was administered using the Structured Clinical Interview (SCI)-PANSS. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG OPC-34712 [Brexpiprazole] High Dose
- DRUG Experimental: OPC-34712 [Brexpiprazole] Middle Dose
- DRUG Experimental: OPC-34712 [Brexpiprazole] Low Dose
Study Locations (20)
California
- - Garden Grove
- - Glendale
- - Oakland
- - Oceanside
- - San Diego
- - San Diego
Florida
- - Bradenton
- - Miami Springs
- - Orlando
Ontario
- - Burlington
- - Chatham
- - Chatham
New York
- - Fresh Meadows
- - Jamaica
South Carolina
- - Charleston
- - Charleston
Arkansas
- - Little Rock
Ohio
- - Dayton
Texas
- - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 636 participants |
| Start Date | 2011-07 |
| Est. Completion | 2014-01 |
| Phase | Phase 3 |
What the finished NCT01396421 record still lists
NCT01396421 is an interventional study that assigns participants to a tested intervention. The registered 636 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (18% lower).
The record links to 1 condition, with Acute Schizophrenia appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT01396421 names 20 study sites across 9 states, led by California, Florida, Ontario.
Frequently Asked Questions
What is clinical trial NCT01396421 about?
NCT01396421 is a clinical study titled "Study of the Effectiveness of Three Different Doses of OPC-34712 in the Treatment of Adults With Acute Schizophrenia". The purpose of this study is to compare the effectiveness, safety and tolerability of three different doses of OPC-34712 with placebo in the treatment of acute schizophrenia in adults.
What is the current status of trial NCT01396421?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 636 participants. The study started on 2011-07. Estimated completion is 2014-01.
What conditions does trial NCT01396421 study?
This clinical trial studies the following conditions: Acute Schizophrenia.
What interventions are being tested in trial NCT01396421?
The interventions under investigation include: Placebo (DRUG), OPC-34712 [Brexpiprazole] High Dose (DRUG), Experimental: OPC-34712 [Brexpiprazole] Middle Dose (DRUG), Experimental: OPC-34712 [Brexpiprazole] Low Dose (DRUG).
Who is sponsoring clinical trial NCT01396421?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01396421 being conducted?
This trial has 20 study locations across Arkansas, California, Florida, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Acute Schizophrenia
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 NCT01396421's enrollment target sits among peer trials
636 579th of 2000 higher than 1,422 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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