Multicenter, Open-label, Safety and Tolerability Study
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: OPC-34712
Intervention description: oral administered once daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 244.0
Sex: All
Minimum age: 18 Years
Maximum age: 67 Years
Healthy volunteers: No
Keywords: Schizophrenia

Summary:

      This will be a multicenter, 52 week, open label study to assess the safety and tolerability
      of oral OPC-34712 (1 to 6 mg) as monotherapy in adult patients with schizophrenia. The study
      will be conducted on an outpatient basis. Enrollment into the study will be drawn from
      eligible subjects who have completed participation in Study 331-07- 203 and who, in the
      investigator's judgment, would benefit from continued treatment with oral OPC-34712.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects who participated in 331-07-203 and who, in the opinion of the investigator,
             have the potential to benefit from continued administration of OPC-34712 for the
             treatment of schizophrenia.

          2. Outpatient status at last visit of Study 331-07-203.

        Exclusion Criteria:

          1. Sexually active males who are not practicing two different methods of birth control
             during the study and for 90 days after the last dose of study medication or who will
             not remain abstinent during the study and for 90 days after the last dose, or sexually
             active females of childbearing potential who are not practicing two different methods
             of birth control during the study and for 30 days after the last dose of study
             medication or who will not remain abstinent during the study and for 30 days after the
             last dose. If employing birth control, two of the following precautions must be used:
             vasectomy, tubal ligation, vaginal diaphragm, intrauterine device, birth control pill,
             birth control depot injection, birth control implant, condom, or sponge with
             spermicide.

          2. Females who are breast-feeding and/or who have a positive pregnancy test result prior
             to receiving open-label OPC-34712.

          3. Subjects who during the course of their participation in 331-07-203 were treated in
             violation of the protocol or who developed ANY exclusion criteria during the course of
             their participation.

          4. Subjects who do not continue to meet all applicable inclusion/exclusion criteria for
             Protocol 331-07-203 at the last visit (ie, Week 6) of Protocol 331-07-203.

          5. Subjects who represent a risk of committing suicide based on an answer of "Yes" to
             either Question 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific
             Plan) or Question 5 (Active Suicidal Ideation with Specific Plan and Intent) on the
             "Suicidal Ideation" portion of the C-SSRS, or an answer of "Yes" to any of the
             suicide-related behaviors (actual attempt, interrupted attempt, aborted attempt,
             preparatory acts or behavior) on the "Suicidal Behavior" portion of the C-SSRS. A
             subject who has had any suicidal ideation within the last 6 months, any suicidal
             behaviors within the last two years, or who in the clinical judgment of the
             investigator presents a serious risk of suicide should be excluded from the study.

          6. Subjects who would be likely to require prohibited concomitant therapy during the
             study.

          7. Any subject who, in the opinion of the investigator, should not participate in the
             study.