An open label study to assess safety and tolerability of OPC-34712 in patients with schizophrenia.

Phase 2

Completed

• Conditions: Health Condition 1: null- SchizophreniaHealth Condition 2: F209- Schizophrenia, unspecified

• Registration Number: CTRI/2009/091/000953
• Lead Sponsor: Otsuka Pharmaceutical Development Commercialization

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 300

Inclusion Criteria

1.Subjects who are able to provide written informed consent (as required by IRB/IEC) prior to the initiation of any protocol-required procedures.

2.Ability, in the opinion of the principal investigator, to understand the nature of the study and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, and discontinuation of prohibited concomitant medication, and to be reliably rated on assessment scales.

3.Subjects who participated in 331-07-203 and who, in the opinion of the investigator, could potentially benefit from administration of OPC-34712 for the treatment of schizophrenia. Eligible subjects include those who completed participation in the Treatment Phase of Protocol 331-07-203 (ie, Week 6 visit), including subjects who initiated open-label OPC-34712 as rescue therapy at Week 4 or Week 5.

4.Outpatient status at last visit of Protocol 331-07-203.

Exclusion Criteria

1.Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving open-label OPC-34712.

Target Disease, Medical History, and Concurrent Diseases

2.Subjects with a major protocol violation during the course of their participation in Protocol 331-07-203.
3.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.
4.Subjects who represent a risk of committing suicide.

Prohibited Therapies or Medications

5.Subjects who would be likely to require prohibited concomitant therapy during the study

Other
6.Any subject who, in the opinion of the investigator, should not participate in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified