RP5063 in Subjects With Schizophrenia or Schizoaffective Disorder (REFRESH)

• ClinicalTrials.gov Identifier: NCT01490086
• Recruitment Status: Completed
• First Posted: December 12, 2011
• Results First Posted: January 26, 2015
• Last Update Posted: January 26, 2015
• Sponsor: Reviva Pharmaceuticals
• Information provided by (Responsible Party): Reviva Pharmaceuticals

Study Description

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

• 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

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

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

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older 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

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; Fundacion REVIVA, Red de VIH del Valle del Cauca

More Information

• Responsible Party: Reviva Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT01490086
• 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:

Schizophrenia; Psychotic Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Aripiprazole; RP5063; Antidepressive Agents; Psychotropic Drugs; Antipsychotic Agents; Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Dopamine Agonists; Dopamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin Agents; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists