NCT01393613

Efficacy Study of OPC-34712 in Adults With Acute Schizophrenia

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Fixed-dose OPC-34712 in the Treatment of Adults With Acute Schizophrenia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 674 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Schizophrenia is a severely debilitating mental illness that affects approximately 1% of the world population. Hallucinations and delusions are the most striking characteristic positive symptoms of schizophrenia; however, more subtle negative symptoms (eg, social withdrawal and lack of emotion, energy, and motivation) may also be present. The first antipsychotics developed for the treatment of schizophrenia were effective against positive symptoms, but showed little efficacy for negative symptoms and were also associated with a high incidence of side effects. Second generation antipsychotics, represent a significant advancement in the treatment of psychotic disorders because they are effective and at the same time exhibit fewer side effects than first generation antipsychotics. Although generally safer than first generation antipsychotics, the second-generation antipsychotics are not devoid of undesirable side effects such as Hyperprolactinemia and weight gain. In addition, the safety of these drugs vary considerably.

Conditions

• Acute Schizophrenia

Interventions

Type	Name	Description
DRUG	OPC-34712	Higher dose tablet, once daily, for six weeks,
DRUG	OPC-34712	Middle dose tablet, once daily, for six weeks
DRUG	OPC-34712	Lower dose tablet, once daily, for six weeks
DRUG	Placebo	Placebo, once daily, for six weeks

Timeline

• Start date: 2011-07-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2011-07-13
• Last updated: 2015-11-26
• Results posted: 2015-11-26

Locations

60 sites across 8 countries: United States, Colombia, Croatia, Mexico, Philippines, Russia, Slovakia, Taiwan