Conditions: Acute Schizophrenia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 636
Healthy volunteers: no

Brief summary:
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.

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 [Brexpiprazole] High Dose intervention 2: Experimental: OPC-34712 [Brexpiprazole] Middle Dose intervention 3: Experimental: OPC-34712 [Brexpiprazole] Low Dose 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: