RP5063 in Subjects With Schizophrenia or Schizoaffective Disorder

Schizoaffective Disorder Clinical Trial

— REFRESH  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01490086
• Other study ID #: RVP-20-001
• Status: Completed
• Phase: Phase 2
• First received: December 7, 2011
• Last updated: January 20, 2015
• Start date: December 2011
• Est. completion date: March 2013

Study information

• Verified date: January 2015
• Source: Reviva Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Acute Schizophrenia
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Drug:
• RP5063
daily
• placebo
daily
• RP5063
daily
• RP5063
daily
• aripiprazole
daily

Locations

Country	Name	City	State
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
Malaysia	Reviva site	Bahru
Malaysia	Reviva site	Johor
Malaysia	Reviva site	KLumpur
Malaysia	Reviva Site	Ridzuan
Moldova, Republic of	Reviva site	Kisinau
Philippines	Reviva site	Mandaluyon
Philippines	Reviva site	Mandurriao
Philippines	Reviva site	Subangdaku
United States	Reviva site	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Reviva Pharmaceuticals

Countries where clinical trial is conducted

United States,  India,  Malaysia,  Moldova, Republic of,  Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No