RP5063 in Subjects With Schizophrenia or Schizoaffective Disorder

NCT01490086 | Completed Phase 2 Results DMC

• 1 other identifier: RVP-20-001
• Study Type: interventional
• Target: 234
• Locations: 5 countries
• Sites: 15

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.

Conditions

Acute Schizophrenia; Schizoaffective Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the Clinical Global Impression Scale - Severity (CGI-S)

  Baseline to Day 28

• Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Positive Subscale

  Baseline to Day 28

• Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Negative Subscale

  Baseline to Day 28

• Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS General Psychopathology Subscale

  Baseline to Day 28

Study Arms (5)

15 mg RP5063 daily

EXPERIMENTAL

RP5063 15 mg once daily

Drug: RP5063

30 mg RP5063 daily

EXPERIMENTAL

RP5063 30 mg once daily

Drug: RP5063

50 mg RP5063 daily

EXPERIMENTAL

RP5063 50 mg once daily

Drug: RP5063

Placebo

PLACEBO COMPARATOR

Placebo once daily

Drug: placebo

aripiprazole

ACTIVE COMPARATOR

aripiprazole 15 mg daily

Drug: aripiprazole

Interventions

RP5063 DRUG

daily

15 mg RP5063 daily; 30 mg RP5063 daily; 50 mg RP5063 daily

placebo DRUG

daily

Placebo

aripiprazole DRUG

daily

Also known as: Abilify

aripiprazole

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Patients with other primary psychiatric disorders as delirium, or bipolar I or II disorder

Sponsors & Collaborators

• Reviva Pharmaceuticals: lead

Study Sites (15)

Reviva site

Philadelphia, Pennsylvania, 19039, United States

Location

Reviva site

Bangalore, India

Location

Reviva site

Chennai, India

Location

Reviva site

Guntur, India

Location

Reviva site

Jaipur, India

Location

Reviva site

Kanpur, India

Location

Reviva site

Lucknow, India

Location

Reviva site

Mangalore, India

Location

Reviva site

Johor Bahru, Malaysia

Location

Reviva site

Kuala Lumpur, Malaysia

Location

Reviva Site

Tanjung Rambutan, Malaysia

Location

Reviva site

Chisinau, Moldova

Location

Reviva site

Mandaluyong, Philippines

Location

Reviva site

Mandurriao, Philippines

Location

Reviva site

Subandaku, Philippines

Location

MeSH Terms

Conditions

Psychotic Disorders

Interventions

RP5063; Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Marc Cantillon, M.D
• Organization: Reviva Pharmaceuticals, Inc.

mcantillon@revivapharma.com

408-960-2209

Study Officials

• M Cantillon

  Fundacion REVIVA, Red de VIH del Valle del Cauca

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2011
• First Posted: December 12, 2011
• Study Start: December 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: August 8, 2025
• Results First Posted: January 26, 2015

Record last verified: 2025-07

Locations

IN (7); US (1); PH (3); MY (3); MO (1)