Clinical trial NCT01490086: RP5063 in Subjects With Schizophrenia or Schizoaffective Disorder
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Schizophrenia
Schizoaffective Disorder
Lead sponsor: Reviva Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-12-12
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Measurement of Schizophrenia Symptoms: Positive and Negative Syndrome Scale (PANSS) Total Score
timeFrame: Baseline to Day 28
Secondary outcomes:
measure: Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the Clinical Global Impression Scale - Severity (CGI-S)
timeFrame: Baseline to Day 28
measure: Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Positive Subscale
timeFrame: Baseline to Day 28
measure: Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Negative Subscale
timeFrame: Baseline to Day 28
measure: Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS General Psychopathology Subscale
timeFrame: Baseline to Day 28
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Reviva site
state: Pennsylvania
city: Bangalore
country: India
facility: Reviva site
city: Chennai
country: India
facility: Reviva site
city: Guntur
country: India
facility: Reviva site
city: Jaipur
country: India
facility: Reviva site
city: Kanpur
country: India
facility: Reviva site
city: Lucknow
country: India
facility: Reviva site
city: Mangalore
country: India
facility: Reviva site
city: Bahru
country: Malaysia
facility: Reviva site
city: Johor
country: Malaysia
facility: Reviva site
city: KLumpur
country: Malaysia
facility: Reviva site
city: Ridzuan
country: Malaysia
facility: Reviva Site
city: Kisinau
country: Moldova, Republic of
facility: Reviva site
city: Mandaluyon
country: Philippines
facility: Reviva site
city: Mandurriao
country: Philippines
facility: Reviva site
city: Subangdaku
country: Philippines
facility: Reviva site
Study officials:
affiliation: Fundacion REVIVA, Red de VIH del Valle del Cauca
name: M Cantillon
role: STUDY_DIRECTOR
References: