RP5063 in Subjects With Schizophrenia or Schizoaffective Disorder

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Acute Schizophrenia, Schizoaffective Disorder

Intervention / Treatment
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* Drug: RP5063
* Drug: placebo
* Drug: RP5063
* Drug: RP5063
* Drug: aripiprazole


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 15mg RP5063 daily<br> | Drug: RP5063<br>* daily<br>|
| Experimental: 30mg RP5063 daily<br> | Drug: RP5063<br>* daily<br>|
| Experimental: 50mg RP5063 daily<br> | Drug: RP5063<br>* daily<br>|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* daily<br>|
| Active Comparator: aripiprazole<br>aripiprazole 15 mg daily | Drug: aripiprazole<br>* daily<br>|

What is the study measuring?
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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 |