Conditions: Acute Schizophrenia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 674
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Higher dose, tablet, once daily, for six weeks arm 2: Middle dose, tablet, once daily, for six weeks arm 3: Lower dose, tablet, once daily, for six weeks arm 4: Placebo, once daily, for six weeks

Interventions: intervention 1: OPC-34712 intervention 2: OPC-34712 intervention 3: OPC-34712 intervention 4: Placebo
Intervention descriptions: intervention 1: Higher dose tablet, once daily, for six weeks, intervention 2: Middle dose tablet, once daily, for six weeks intervention 3: Lower dose tablet, once daily, for six weeks intervention 4: Placebo, once daily, for six weeks

Protocol document: