Aripiprazole Used as Dual Therapy in the Treatement of Patients With Chronic Stable Schizophrenia or Schizoaffective Disorder.

Phase 4

Completed

• Conditions: Schizophrenia; Schizoaffective Disorder
• Interventions: Drug: Quetiapine or Risperidone + Aripiprazole; Drug: Quetiapine or Risperidone + placebo

• Registration Number: NCT00325689
• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary

A Multicenter, Double-blind 16 Week Study on the augmentation of atypical antipsychotic with Aripiprazole in patients with Schizophrenia with inadequate response to antipsychotic treatment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-05-11
• Study First Submitted QC: 2006-05-12
• Study First Posted: 2006-05-15
• Study Start: 2006-07
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2011-04
• Last Update Submitted: 2013-11-07
• Last Update Posted: 2013-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 323

Inclusion Criteria

• Patient with diagnosis of chronic Schizophrenia or Schizoaffective disorder
• Stable symptoms and dose of Quetiapine or Risperidone

Exclusion Criteria

• First diagnosis in the past year
• Significant risk of suicide or meet DSM-IV-TR criteria for substance abuse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Quetiapine or Risperidone + Aripiprazole	Quetiapine or Risperidone + Aripiprazole	-
Quetiapine or Risperidone + placebo	Quetiapine or Risperidone + placebo	-

Primary Outcome Measures

Name	Time	Method
Evaluate the efficacy of adding Aripiprazole to atypical antipsychotic treatment via Positive and Negative Symptoms Scale (PANSS) score at endpoint	(Week 16) or at time of discontinuation

Secondary Outcome Measures

Name	Time	Method
Assess efficacy according to changes in the severity of illness symptoms as measured by the Clinical Global Impressions-Severity (CGI-S)	at endpoint (Week 16)

Trial Locations

Locations (47)

K & S Professional Research Services, Llc; 🇺🇸 Little Rock, Arkansas, United States

Comprehensive Neuroscience, Inc.; 🇺🇸 Cerritos, California, United States

Atp Clinical Research, Inc.; 🇺🇸 Costa Mesa, California, United States

Collaborative Neuroscience Network, Inc.; 🇺🇸 Garden Grove, California, United States

San Fernando Mental Health Center; 🇺🇸 Granada Hills, California, United States

Uci Medical Center; 🇺🇸 Orange, California, United States

California Clinical Trials Medical Group; 🇺🇸 Paramount, California, United States

California Clinical Trials; 🇺🇸 San Diego, California, United States

Sharp Mesa Vista Hospital; 🇺🇸 San Diego, California, United States

California Neuropsychopharmacology Clinical Research Inst.; 🇺🇸 San Diego, California, United States

Scroll for more (37 remaining)