Phase 2
N=234
RP5063 in Subjects With Schizophrenia or Schizoaffective Disorder
Acute Schizophrenia · Schizoaffective Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01490086 ↗Enrolled (actual)
234
Serious AEs
2.2%
Results posted
Jan 2015
Primary outcome: Primary: Measurement of Schizophrenia Symptoms: Positive and Negative Syndrome Scale (PANSS) Total Score — 87.57; 88.74; 85.88; 91.68 scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- RP5063 (Drug); placebo (Drug); aripiprazole (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Reviva Pharmaceuticals
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measurement of Schizophrenia Symptoms: Positive and Negative Syndrome Scale (PANSS) Total Score |
87.57; 88.74; 85.88; 91.68; 89.84; 67.34 | — |
| SECONDARY Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the Clinical Global Impression Scale - Severity (CGI-S) |
4.79; 4.81; 4.75; 4.84; 4.76; 3.48 | — |
| SECONDARY Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Positive Subscale |
24.79; 23.77; 23.68; 25.42; 24.54; 17.82 | — |
| SECONDARY Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Negative Subscale |
21.80; 22.89; 21.37; 22.53; 22.24; 16.96 | — |
| SECONDARY Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS General Psychopathology Subscale |
40.98; 42.07; 40.82; 43.74; 43.05; 32.55 | — |
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 Criteria
- 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 Criteria
- Patients with other primary psychiatric disorders as delirium, or bipolar I or II disorder
Data sourced from ClinicalTrials.gov (NCT01490086). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.