Study to Evaluate the Efficacy, Safety, and Tolerability of Oral OPC-34712 and Aripiprazole for Treatment of Acute Schizophrenia

Completed · Phase 2 · Has a placebo group

Conditions studied: Schizophrenia

In brief

This will be a multicenter, randomized, double-blind, placebo-controlled study designed to assess the tolerability, safety, and efficacy of OPC-34712 (0.25 to 6.0 mg) for the treatment of adult subjects hospitalized with an acute relapse of schizophrenia. Aripiprazole (10 to 20 mg) is included as a positive control to confirm the assay sensitivity of the study. A total of approximately 563 subjects will be screened at an estimated 75 sites worldwide in order to obtain approximately 450 randomized subjects.

Key facts

Study ID

NCT00905307

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

459

Starts

2009-07-01

Expected to finish

2010-11-01

Last updated by the study team

2015-10-20

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

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 inclusion/exclusion criteria may apply

Where it is running

• Study Site — Escondido, California, United States
• Study Site — Garden Grove, California, United States
• Study Site — Long Beach, California, United States
• Study Site — Oceanside, California, United States
• Study Site — Pasadena, California, United States
• Study Site — San Diego, California, United States
• Study Site — San Diego, California, United States
• Study Site — Santa Ana, California, United States
• Study Site — Washington D.C., District of Columbia, United States
• Study Site — Bradenton, Florida, United States
• Study Site — Maitland, Florida, United States
• Study Site — St Louis, Missouri, United States
• Study Site — Cedarhurst, New York, United States
• Study Site — Philadelphia, Pennsylvania, United States
• Study Site — Austin, Texas, United States
• Study Site — Burgas, Bulgaria
• Study Site — Kazanlak, Bulgaria
• Study Site — Pazardzhik, Bulgaria
• Study Site — Plovdiv, Bulgaria
• Study Site — Radnevo, Bulgaria
• Study Site — Rousse, Bulgaria
• Study Site — Rijeka, Croatia
• Study Site — Split, Croatia
• Study Site — Zagreb, Croatia
• Study Site — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.