Safety and Tolerability Study of Oral OPC-34712 as Maintenance Treatment in Adults With Schizophrenia (ZENITH)

• 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 ]

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:

1. Male or female subjects between 18 and 65 years of age, with a diagnosis of schizophrenia, as defined by DSM-IV-TR criteria
2. Outpatient status at last visit of Trial 331-10-230 or Trial 331-10-231
3. Willing to discontinue all prohibitive psychotropic medications to meet protocol required washouts prior to and during the trial period.
4. Other protocol specific inclusion criteria may apply.

Exclusion Criteria:

1. Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug

2. Subjects with a current DSM-IV-TR Axis I diagnosis of:

   • Schizoaffective disorder
   • MDD
   • Bipolar disorder
   • Delirium, dementia, amnestic or other cognitive disorder
   • Borderline, paranoid, histrionic, schizotypal, schizoid or antisocial personality disorder
3. Subjects presenting with a first episode of schizophrenia
4. Other protocol specific exclusion criteria may apply.