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

Otsuka

Status and phase: Completed; Phase 4

Conditions: Schizophrenia; Schizoaffective Disorder

Treatments: Drug: Quetiapine or Risperidone + placebo; Drug: Quetiapine or Risperidone + Aripiprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00325689

CN138-397 ST

Details and patient eligibility

About

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.

Enrollment: 323 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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323 participants in 2 patient groups, including a placebo group

Quetiapine or Risperidone + Aripiprazole

Active Comparator group

Treatment:

Drug: Quetiapine or Risperidone + Aripiprazole

Quetiapine or Risperidone + placebo

Placebo Comparator group

Treatment:

Drug: Quetiapine or Risperidone + placebo