Status:
COMPLETED
Safety and Tolerability Study of Oral OPC-34712 as Maintenance Treatment in Adults With Schizophrenia
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
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.
Detailed Description
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 sc...
Eligibility Criteria
Inclusion
- Male or female subjects between 18 and 65 years of age, with a diagnosis of schizophrenia, as defined by DSM-IV-TR criteria
- Outpatient status at last visit of Trial 331-10-230 or Trial 331-10-231
- Willing to discontinue all prohibitive psychotropic medications to meet protocol required washouts prior to and during the trial period.
- Other protocol specific inclusion criteria may apply.
Exclusion
- Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug
- 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
- Subjects presenting with a first episode of schizophrenia
- Other protocol specific exclusion criteria may apply.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
1044 Patients enrolled
Trial Details
Trial ID
NCT01397786
Start Date
September 1 2011
End Date
January 1 2016
Last Update
May 10 2017
Active Locations (148)
Enter a location and click search to find clinical trials sorted by distance.
1
Birmingham, Alabama, United States, 35226
2
Little Rock, Arkansas, United States, 72201
3
Little Rock, Arkansas, United States, 72205
4
Springdale, Arkansas, United States, 72764