RP5063 in Subjects With Schizophrenia or Schizoaffective Disorder (REFRESH)

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Acute Schizophrenia; Schizoaffective Disorder	Drug: RP5063; Drug: placebo; Drug: aripiprazole	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	234 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, 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
Study Start Date :	December 2011
Actual Primary Completion Date :	March 2013
Actual Study Completion Date :	March 2013

Arms and Interventions

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Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. Measurement of Schizophrenia Symptoms: Positive and Negative Syndrome Scale (PANSS) Total Score [ Time Frame: Baseline to Day 28 ]
   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.

Secondary Outcome Measures :

1. Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the Clinical Global Impression Scale - Severity (CGI-S) [ Time Frame: Baseline to Day 28 ]
   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.
2. Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Positive Subscale [ Time Frame: Baseline to Day 28 ]
   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.
3. Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Negative Subscale [ Time Frame: Baseline to Day 28 ]
   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.
4. Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS General Psychopathology Subscale [ Time Frame: Baseline to Day 28 ]
   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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Reviva Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01490086 History of Changes
Other Study ID Numbers:	RVP-20-001
First Posted:	December 12, 2011
Results First Posted:	January 26, 2015
Last Update Posted:	January 26, 2015
Last Verified:	January 2015

Additional relevant MeSH terms:

Disease; Schizophrenia; Psychotic Disorders; Pathologic Processes; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders	Aripiprazole; Antipsychotic Agents; Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Psychotropic Drugs