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RP5063 in Subjects With Schizophrenia or Schizoaffective Disorder (REFRESH)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Reviva Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01490086
First received: December 7, 2011
Last updated: March 16, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Acute Schizophrenia
Schizoaffective Disorder
 Drug: RP5063
Drug: placebo
Drug: aripiprazole
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Further study details as provided by Reviva Pharmaceuticals:

Primary Outcome Measures:
  • Measurement of schizophrenia symptoms: Positive and Negative Syndrome Scale (PANSS) total score [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measurement of schizophrenia symptoms: Clinical Global Impression-Severity (CGI-S) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 228
Study Start Date: December 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 15mg RP5063 daily Drug: RP5063
daily
Experimental: 30mg RP5063 daily Drug: RP5063
daily
Experimental: 50mg RP5063 daily Drug: RP5063
daily
Placebo Comparator: Placebo Drug: placebo
daily
Active Comparator: aripiprazole
aripiprazole 15 mg daily
 Drug: aripiprazole
daily

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01490086

Locations
United States, Pennsylvania
Reviva site
Philadelphia, Pennsylvania, United States, 19039
India
Reviva site
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
Malaysia
Reviva site
Bahru, Malaysia
Reviva site
Johor, Malaysia
Reviva site
KLumpur, Malaysia
Reviva Site
Ridzuan, Malaysia
Moldova, Republic of
Reviva site
Kisinau, Moldova, Republic of
Philippines
Reviva site
Mandaluyon, Philippines
Reviva site
Mandurriao, Philippines
Reviva site
Subangdaku, Philippines
Sponsors and Collaborators
Reviva Pharmaceuticals
Investigators
Study Director: M Cantillon Reviva
  More Information

No publications provided

Responsible Party: Reviva Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01490086     History of Changes
Other Study ID Numbers: RVP-20-001
Study First Received: December 7, 2011
Last Updated: March 16, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 19, 2013