Status:
COMPLETED
RP5063 in Subjects With Schizophrenia or Schizoaffective Disorder
Lead Sponsor:
Reviva Pharmaceuticals
Conditions:
Acute Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The objective of this study is to evaluate the efficacy and safety of RP5063 relative to placebo for the treatment of schizophrenia or schizoaffective disorder.
Eligibility Criteria
Inclusion
- Patients providing informed consent prior to any study specific procedures
- Patients meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia (paranoid type, disorganized type, catatonic type or undifferentiated type), or schizoaffective disorder
- Patients with normal physical examination, laboratory, vital signs,and electrocardiogram (ECG)
Exclusion
- Patients with other primary psychiatric disorders as delirium, or bipolar I or II disorder
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
234 Patients enrolled
Trial Details
Trial ID
NCT01490086
Start Date
December 1 2011
End Date
March 1 2013
Last Update
August 8 2025
Active Locations (15)
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1
Reviva site
Philadelphia, Pennsylvania, United States, 19039
2
Reviva site
Bangalore, India
3
Reviva site
Chennai, India
4
Reviva site
Guntur, India