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COMPLETED Phase 3

Study of the Effectiveness of Three Different Doses of OPC-34712 in the Treatment of Adults With Acute Schizophrenia

NCT01396421 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 636 participants
Start Date 2011-07
Est. Completion 2014-01
Phase Phase 3

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01396421

The ClinicalTrials.gov registry entry for NCT01396421 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 636 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 79 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01396421 reports 20 study locations spanning 9 distinct geographic areas — top geographies include California, Florida, Ontario. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01396421?

This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 79 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial