Efficacy Study of OPC-34712 in Adults With Acute Schizophrenia

Completed · Phase 3 · Has a placebo group

Conditions studied: Acute Schizophrenia

In brief

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.

Key facts

Study ID

NCT01393613

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

674

Starts

2011-07-01

Expected to finish

2014-02-01

Last updated by the study team

2015-11-26

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 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
• 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 — Springdale, Arkansas, United States
• Study site — Escondido, California, United States
• Study site — Long Beach, California, United States
• Study site — Orange, California, United States
• Study site — Pico Rivera, California, United States
• Study site — San Diego, California, United States
• Study site — North Miami, Florida, United States
• Study site — North Miami, Florida, United States
• Study site — Overland Park, Kansas, United States
• Study site — Lake Charles, Louisiana, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Flowood, Mississippi, United States
• Study site — St Louis, Missouri, United States
• Study site — Buffalo, New York, United States
• Study site — Memphis, Tennessee, United States
• Study site — Austin, Texas, United States
• Study site — Dallas, Texas, United States
• Study site — Houston, Texas, United States
• Study site — Bogotá, Colombia
• Study site — Medellín, Colombia
• Study site — Pereira, Colombia
• Study site — Rijeka, Croatia
• Study site — Zagreb, Croatia
• Study site — Zagreb, Croatia
• Study site — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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