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

This study has been completed.

Sponsor:

Collaborator:

Otsuka America Pharmaceutical

Information provided by:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT00325689

First received: May 11, 2006

Last updated: April 22, 2011

Last verified: April 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

May 11, 2006

Last Updated Date

April 22, 2011

Start Date ^ICMJE

July 2006

Primary Completion Date

October 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Evaluate the efficacy of adding Aripiprazole to atypical antipsychotic treatment via Positive and Negative Symptoms Scale (PANSS) score at endpoint [ Time Frame: (Week 16) or at time of discontinuation ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Evaluate the efficacy of adding Aripiprazole to atypical antipsychotic treatment via Mean Clinical Global Impressions - Improvement (CGI-I) score at endpoint (Week 16) or at time of discontinuation.

Change History

Complete list of historical versions of study NCT00325689 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Assess efficacy according to changes in the severity of illness symptoms as measured by the Clinical Global Impressions-Severity (CGI-S) [ Time Frame: at endpoint (Week 16) ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Assess efficacy of treatment by changes in the severity of symptoms measured by the Clinical Global Impressions-Severity, the Positive and Negative Symptoms Scale, and the Calgary Depression Scale for Schizophrenia at endpoint (Week 16).

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Multicenter, Randomized, Double-blind, Placebo-controlled, 16 Week Study of Aripiprazole Used as Dual Therapy in the Treatment of Patients With Chronic Stable Schizophrenia or Schizoaffective Disorder Demonstrating an Inadequate Response to Quetiapine or Risperidone Monotherapy.

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Schizophrenia
Schizoaffective Disorder

Intervention ^ICMJE

Drug: Quetiapine or Risperidone + Aripiprazole
Tablets, Oral, Quetiapine 400-800 mg/day or Risperidone (4-8 mg/day) + Aripiprazole 2-15 mg/day, Flexible, 16 weeks.

Other Name: Abilify
Drug: Quetiapine or Risperidone + placebo
Tablets, Oral, Quetiapine 400-800 mg/day or Risperidone (4-8 mg/day) + Placebo, Flexible, 16 weeks.

Study Arm (s)

Active Comparator: Quetiapine or Risperidone + Aripiprazole
Intervention: Drug: Quetiapine or Risperidone + Aripiprazole
Placebo Comparator: Quetiapine or Risperidone + placebo
Intervention: Drug: Quetiapine or Risperidone + placebo

Publications *

Kane JM, Correll CU, Goff DC, Kirkpatrick B, Marder SR, Vester-Blokland E, Sun W, Carson WH, Pikalov A, Assunção-Talbott S. A multicenter, randomized, double-blind, placebo-controlled, 16-week study of adjunctive aripiprazole for schizophrenia or schizoaffective disorder inadequately treated with quetiapine or risperidone monotherapy. J Clin Psychiatry. 2009 Oct;70(10):1348-57.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

323

Completion Date

October 2007

Primary Completion Date

October 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00325689

Other Study ID Numbers ^ICMJE

CN138-397 ST

Has Data Monitoring Committee

Not Provided

Responsible Party

Study Director, Bristol-Myers Squibb

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Otsuka America Pharmaceutical

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

April 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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