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NCT01393613 · ClinicalTrials.gov registry record · Phase 3
Efficacy Study of OPC-34712 in Adults With Acute Schizophrenia
A Phase 3 study of Acute Schizophrenia, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 3
- Development phase
- 674
- Enrollment target
- 20
- Study locations
NCT01393613: Completed Phase 3 study of Acute Schizophrenia, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT01393613 is a Phase 3 study of Acute Schizophrenia that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 674 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (13% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01393613, a Phase 3 study of Acute Schizophrenia, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 674 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to assess the efficacy, safety, and tolerability of fixed doses of OPC-34712 versus placebo for the treatment of adult subjects with an acute relapse of schizophrenia.
Primary Outcome
The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG OPC-34712
Study Locations (20)
California
- - Escondido
- - Long Beach
- - Orange
- - Pico Rivera
- - San Diego
Texas
- - Austin
- - Dallas
- - Houston
Arkansas
- - Little Rock
- - Springdale
Florida
- - North Miami
- - North Miami
Louisiana
- - Lake Charles
- - Shreveport
Kansas
- - Overland Park
Mississippi
- - Flowood
Missouri
- - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 674 participants |
| Start Date | 2011-07 |
| Est. Completion | 2014-02 |
| Phase | Phase 3 |
What the finished NCT01393613 record still lists
NCT01393613 is an interventional study that assigns participants to a tested intervention. The registered 674 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 (13% lower).
The record links to 1 condition, with Acute Schizophrenia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01393613 names 20 study sites across 11 states, led by California, Texas, Arkansas.
Frequently Asked Questions
What is clinical trial NCT01393613 about?
NCT01393613 is a clinical study titled "Efficacy Study of OPC-34712 in Adults With Acute Schizophrenia". The purpose of this study is to assess the efficacy, safety, and tolerability of fixed doses of OPC-34712 versus placebo for the treatment of adult subjects with an acute relapse of schizophrenia.
What is the current status of trial NCT01393613?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 674 participants. The study started on 2011-07. Estimated completion is 2014-02.
What conditions does trial NCT01393613 study?
This clinical trial studies the following conditions: Acute Schizophrenia.
What interventions are being tested in trial NCT01393613?
The interventions under investigation include: Placebo (DRUG), OPC-34712 (DRUG).
Who is sponsoring clinical trial NCT01393613?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01393613 being conducted?
This trial has 20 study locations across Arkansas, California, Florida, Kansas, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT01393613's enrollment target sits among peer trials
674 543rd of 2000 higher than 1,457 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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