RP5063 in Subjects With Schizophrenia or Schizoaffective Disorder - Full Text View

Purpose

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	Intervention	Phase
Acute Schizophrenia Schizoaffective Disorder	Drug: RP5063 Drug: placebo Drug: aripiprazole	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Genetics Home Reference related topics: schizophrenia

MedlinePlus related topics: Schizophrenia

Drug Information available for: Aripiprazole

U.S. FDA Resources

Further study details as provided by Reviva Pharmaceuticals:

Primary Outcome Measures:

Measurement of Schizophrenia Symptoms: Positive and Negative Syndrome Scale (PANSS) Total Score [ Time Frame: Baseline to Day 28 ] [ Designated as safety issue: No ]
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:

Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the Clinical Global Impression Scale - Severity (CGI-S) [ Time Frame: Baseline to Day 28 ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline to Day 28 ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline to Day 28 ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline to Day 28 ] [ Designated as safety issue: No ]
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.


Enrollment:	234
Study Start Date:	December 2011
Study Completion Date:	March 2013
Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	18 Years to 65 Years (Adult)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01490086

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


Responsible Party:	Reviva Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01490086 History of Changes
Other Study ID Numbers:	RVP-20-001
Study First Received:	December 7, 2011
Results First Received:	January 12, 2015
Last Updated:	January 20, 2015
Health Authority:	United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 28, 2016

RP5063 in Subjects With Schizophrenia or Schizoaffective Disorder (REFRESH)