CompletedPhase 2

RP5063 in Subjects With Schizophrenia or Schizoaffective Disorder

United States, India234 participantsStarted 2011-12

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Measurement of Schizophrenia Symptoms: Positive and Negative Syndrome Scale (PANSS) Total Score

Timeframe: Baseline to Day 28

Trial details

NCT IDNCT01490086

SponsorReviva Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-03

Results submitted2015-01-12

View on ClinicalTrials.gov More Acute Schizophrenia trials