A Long-term, Phase 3, Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Oral OPC-34712 as Maintenance Treatment in Adults With Schizophrenia
A Long-term, Phase 3, Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Oral OPC-34712 as Maintenance Treatment in Adults With Schizophrenia
The purpose of this study is to assess the long-term safety, tolerability and efficacy of oral OPC-34712 as monotherapy in adults with schizophrenia.
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.
Inclusion Criteria:
Exclusion Criteria:
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:
Subjects presenting with a first episode of schizophrenia
Other protocol specific exclusion criteria may apply.
Fujisawa-shi, Kanagawa 251-8530, Japan
Kunigami-gun, Okinawa 904-1201, Japan
Sakai-shi, Osaka 590-0018, Japan
Jalan Greentown, 30450, Malaysia
Col. Florida, Mexico City 01030, Mexico
Moscow Region, 142601, Russia
Village Nikolskoe, 188357, Russia
Kashsiung, 802, Taiwan
Taoyuan County, 333, Taiwan