Aripiprazole Used as Dual Therapy in the Treatement of Patients With Chronic Stable Schizophrenia or Schizoaffective Disorder.
NCT00325689 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 323
Last updated 2013-11-08
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.
Conditions
- Schizophrenia
- Schizoaffective Disorder
Interventions
- 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.
- DRUG
-
Quetiapine or Risperidone + placebo
Tablets, Oral, Quetiapine 400-800 mg/day or Risperidone (4-8 mg/day) + Placebo, Flexible, 16 weeks.
Sponsors & Collaborators
-
Otsuka America Pharmaceutical
collaborator INDUSTRY -
Otsuka Pharmaceutical Development & Commercialization, Inc.
lead INDUSTRY
Principal Investigators
-
Bristol-Myers Squibb · Bristol-Myers Squibb
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-07-31
- Primary Completion
- 2007-10-31
- Completion
- 2007-10-31
Countries
- United States
Study Locations
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