RP5063 in Subjects With Schizophrenia or Schizoaffective Disorder (REFRESH)

REFRESH : Randomized Double-blind, Placebo-controlled, Multicenter Trial to Assess the Safety and Efficacy of RP5063 in Subjects With an Acute Exacerbation of Schizophrenia or Schizoaffective Disorder

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.

Study Overview

• Status: Completed
• Conditions: Schizoaffective Disorder; Acute Schizophrenia
• Intervention / Treatment: Drug: RP5063; Drug: placebo; Drug: aripiprazole

• Study Type: Interventional
• Enrollment (Actual): 234
• Phase: Phase 2

Contacts and Locations

Study Locations

• India
  • Bangalore, India
    • Reviva site
  • Chennai, India
    • Reviva site
  • Guntur, India
    • Reviva site
  • Jaipur, India
    • Reviva site
  • Kanpur, India
    • Reviva site
  • Lucknow, India
    • Reviva site
  • Mangalore, India
    • Reviva site
• Malaysia
  • Johor Bahru, Malaysia
    • Reviva site
  • Kuala Lumpur, Malaysia
    • Reviva site
  • Tanjung Rambutan, Malaysia
    • Reviva site
• Moldova, Republic of
  • Chisinau, Moldova, Republic of
    • Reviva site
• Philippines
  • Mandaluyong, Philippines
    • Reviva site
  • Mandurriao, Philippines
    • Reviva site
  • Subandaku, Philippines
    • Reviva site
• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19039
      • Reviva site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo once daily	Drug: placebo; daily
Experimental: 15 mg RP5063 daily; RP5063 15 mg once daily	Drug: RP5063; daily
Experimental: 30 mg RP5063 daily; RP5063 30 mg once daily	Drug: RP5063; daily
Experimental: 50 mg RP5063 daily; RP5063 50 mg once daily	Drug: RP5063; daily
Active Comparator: aripiprazole; aripiprazole 15 mg daily	Drug: aripiprazole; daily; Other Names: Abilify

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of Schizophrenia Symptoms: Positive and Negative Syndrome Scale (PANSS) Total Score	PANSS total score comprises Positive (Delusions, Conceptual disorganization, Hallucinatory behavior, Excitement, Grandiosity, Suspiciousness/persecution, Hostility), Negative (Blunted affect, Emotional withdrawal, Poor rapport, Passive/apathetic social withdrawal, Difficulty in abstract thinking, Lack of spontaneity and flow of conversation, Stereotyped thinking), and General Psychopathology (Somatic concern, Anxiety, Guilt feelings, Tension, Mannerisms and posturing, Depression, Motor retardation, Uncooperativeness, Unusual thought content, Disorientation, Poor attention, Lack of judgment and insight, Disturbance of volition, Poor impulse control, Preoccupation, Active social avoidance) Scales. Scores are obtained by adding the ratings of each item in each scale. Range is 7-49 for Positive and Negative scores; 16-112 for General Psychopathology score; and 30-210 for Total score. Higher score reflects worse outcome; larger reduction from baseline reflects better outcome.	Baseline to Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the Clinical Global Impression Scale - Severity (CGI-S)	Clinical Global Impression, Severity (CGI-S) is a single-item (7-point) scale that evaluates the overall severity of the subject's mental illness. Scores range from 1 (not ill at all) to 7 (among the most extremely ill). A reduction in score indicates an improvement in the subject's condition.	Baseline to Day 28
Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Positive Subscale	The Positive Scale includes 7 Items (Delusions, Conceptual disorganization, Hallucinations, Hyperactivity, Grandiosity, Suspiciousness/persecution, Hostility) and is calculated by adding the subscale item scores to obtain results ranging from 7 to 49. A higher score reflects worse outcome and a larger reduction in the score from baseline reflects better treatment efficacy.	Baseline to Day 28
Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Negative Subscale	The Negative Scale includes 7 items (Blunted affect, Emotional withdrawal, Poor rapport, Passive/apathetic social withdrawal, Difficulty in abstract thinking, Lack of spontaneity and flow of conversation, Stereotyped thinking) and is calculated by adding the negative subscale item scores to obtain results ranging from 7 to 49. Minimum score is 7, maximum score is 49. A higher score reflects worse outcome and a larger reduction in the score from baseline reflects better treatment efficacy.	Baseline to Day 28
Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS General Psychopathology Subscale	The General Psychopathology Scale consists of 16 items (Somatic concern, Anxiety, Guilt feelings, Tension, Mannerisms and posturing, Depression, Motor retardation, Uncooperativeness, Unusual thought content, Disorientation, Poor attention, Lack of judgment and insight, Disturbance of volition, Poor impulse control, Preoccupation, Active social avoidance). The General Psychopathology score is obtained by adding the ratings of each item in the scale, with results ranging from 16 to 112. A higher score reflects worse outcome and a larger reduction in the score from baseline reflects better treatment efficacy.	Baseline to Day 28

Collaborators and Investigators

• Sponsor: Reviva Pharmaceuticals
• Investigators: Study Director: M Cantillon, Fundacion REVIVA, Red de VIH del Valle del Cauca

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: December 7, 2011
• First Submitted That Met QC Criteria: December 9, 2011
• First Posted (Estimated): December 12, 2011

Study Record Updates

• Last Update Posted (Actual): August 8, 2025
• Last Update Submitted That Met QC Criteria: July 21, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Schizophrenia; Psychotic Disorders; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Neurotransmitter Agents; Tranquilizing Agents; Psychotropic Drugs; Dopamine Agents; Dopamine Agonists; Antidepressive Agents; Serotonin Antagonists; Serotonin Agents; Antipsychotic Agents; Serotonin 5-HT2 Receptor Antagonists; Dopamine Antagonists; Serotonin Receptor Agonists; Serotonin 5-HT1 Receptor Agonists; Dopamine D2 Receptor Antagonists; Aripiprazole; RP5063
• Other Study ID Numbers: RVP-20-001