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:
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT00325689
First received: May 11, 2006
Last updated: November 7, 2013
Last verified: April 2011

May 11, 2006
November 7, 2013
July 2006
October 2007   (final data collection date for primary outcome measure)
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 ]
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.
Complete list of historical versions of study NCT00325689 on ClinicalTrials.gov Archive Site
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 ]
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).
Not Provided
Not Provided
 
Aripiprazole Used as Dual Therapy in the Treatement of Patients With Chronic Stable Schizophrenia or Schizoaffective Disorder.
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.

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Schizophrenia
  • Schizoaffective Disorder
  • 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.
  • Active Comparator: Quetiapine or Risperidone + Aripiprazole
    Intervention: Drug: Quetiapine or Risperidone + Aripiprazole
  • Placebo Comparator: Quetiapine or Risperidone + placebo
    Intervention: Drug: Quetiapine or Risperidone + placebo
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.
 
Completed
323
October 2007
October 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00325689
CN138-397 ST
Not Provided
Study Director, Bristol-Myers Squibb
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka America Pharmaceutical
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Otsuka Pharmaceutical Development & Commercialization, Inc.
April 2011

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