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

• Conditions: Acute Schizophrenia; MedDRA version: 14.1Level: LLTClassification code 10001064Term: Acute schizophreniaSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2011-002514-37-LV
• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-25
• Last Update Posted: 2 May 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1000

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1000
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the long-term safety and tolerability of oral OPC-34712 as monotherapy in adults with schizophrenia.<br>This trial is to be conducted on an outpatient basis. ;Secondary Objective: To assess the long-term efficacy of oral OPC-34712 as monotherapy in adults with schizophrenia.;Primary end point(s): •Outcome Measure - safety and tolerability of OPC-34712 to be assessed by examining the frequency and severity of adverse events. <br><br>;Timepoint(s) of evaluation of this end point: up to 52 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Change in Positive and Negative Syndrome Scale Positive Subscale, Negative Subscale and Total Scores. <br><br>Change in Clinical Global Impression -Severity of Illness scale score<br><br>?Change in Personal and Social Performance scale Total Score<br>?Mean Clinical Global Impression - Improvement scale score<br>?Improved Response rate<br>?Discontinuation rate for lack of efficacy<br><br><br>•Complete Physical Exam, including Clinical Laboratory Tests ;Timepoint(s) of evaluation of this end point: up to 52 weeks