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

Completed · Phase 3 · Has a placebo group

Conditions studied: Acute Schizophrenia

In brief

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.

Key facts

Study ID

NCT01396421

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

636

Starts

2011-07-01

Expected to finish

2014-01-01

Last updated by the study team

2015-10-29

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subjects between 18 and 65 years of age, with a diagnosis of schizophrenia, as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria
• Subjects who have been recently hospitalized or who would benefit from hospitalization for an acute relapse of schizophrenia
• Subjects experiencing an acute exacerbation of psychotic symptoms
• Other protocol specific inclusion criteria may apply

You may not qualify if…

• Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug
• Subjects with a current DSM-IV-TR Axis I diagnosis of:
• Schizoaffective disorder
• Major depressive disorder (MDD)
• Bipolar disorder
• Delirium, dementia, amnestic or other cognitive disorder
• Borderline, paranoid, histrionic, schizotypal, schizoid or antisocial personality disorder
• Subjects presenting with a first episode of schizophrenia
• Other protocol specific exclusion criteria may apply

Where it is running

• Study site — Garden Grove, California, United States
• Study site — Glendale, California, United States
• Study site — Oakland, California, United States
• Study site — Oceanside, California, United States
• Study site — San Diego, California, United States
• Study site — San Diego, California, United States
• Study site — Bradenton, Florida, United States
• Study site — Miami Springs, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Fresh Meadows, New York, United States
• Study site — Jamaica, New York, United States
• Study site — Dayton, Ohio, United States
• Study site — Charleston, South Carolina, United States
• Study site — Charleston, South Carolina, United States
• Study site — Austin, Texas, United States
• Study site — Kirkland, Washington, United States
• Study site — Burlington, Ontario, Canada
• Study site — Chatham, Ontario, Canada
• Study site — Chatham, Ontario, Canada
• Study site — Fujisawa-shi, Kanagawa, Japan
• Study site — Kunigami-gun, Okinawa, Japan
• Study site — Sakai-shi, Osaka, Japan
• Study site — Setagaya-ku, Tokyo-To, Japan
• Study site — Kumamoto, Japan
• Study site — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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