RP5063 in Subjects With Schizophrenia or Schizoaffective Disorder

Phase 2

Completed

• Conditions: Acute Schizophrenia; Schizoaffective Disorder
• Interventions: Drug: placebo; Drug: RP5063; Drug: aripiprazole

• Registration Number: NCT01490086
• Lead Sponsor: Reviva Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-07
• Study First Submitted QC: 2011-12-09
• Study First Posted: 2011-12-12
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2015-01
• Results First Submitted: 2015-01-12
• Results First Submitted QC: 2015-01-20
• Last Update Submitted: 2015-01-20
• Results First Posted: 2015-01-26
• Last Update Posted: 2015-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 234

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)

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	-
30mg RP5063 daily	RP5063	-
15mg RP5063 daily	RP5063	-
50mg RP5063 daily	RP5063	-
aripiprazole	aripiprazole	aripiprazole 15 mg daily

Primary Outcome Measures

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

Name	Time	Method
Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the Clinical Global Impression Scale - Severity (CGI-S)	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.
Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Positive Subscale	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.
Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Negative Subscale	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.
Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS General Psychopathology Subscale	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.

Trial Locations

Locations (2)

Reviva Site; 🇲🇾 Ridzuan, Malaysia

Reviva site; 🇵🇭 Subangdaku, Philippines