Safety and Tolerability Study of Oral OPC-34712 as Maintenance Treatment in Adults With Schizophrenia (ZENITH)
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.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Outcome Measure - safety and tolerability of OPC-34712 to be assessed by examining the frequency and severity of adverse events. [ Time Frame: up to 52 weeks ] [ Designated as safety issue: Yes ]
- Change in Positive and Negative Syndrome Scale Positive Subscale, Negative Subscale and Total Scores. [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
Change in Clinical Global Impression -Severity of Illness scale score
- Change in Personal and Social Performance scale Total Score
- Mean Clinical Global Impression - Improvement scale score
- Improved Response rate
- Discontinuation rate for lack of efficacy
- Complete Physical Exam, including Clinical Laboratory Tests [ Time Frame: up to 52 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
Phase A: 1-2 mgs/day by mouth, max of 4 wks.
Phase B: 1-4 mgs/day by mouth, up to 52 weeks
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.
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