A Study of Adjunctive Treatment of Aripiprazole in Schizophrenic Patients

Otsuka

Status and phase: Completed; Phase 4

Conditions: Schizophrenia

Treatments: Drug: Placebo; Drug: aripiprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00300846

CN138-170

Details and patient eligibility

About

The purpose of this study is to evaluate the effect on patient weight of adjunctive therapy of aripiprazole with clozapine versus clozapine monotherapy, in schizophrenic patients who are not optimally controlled on clozapine.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with schizophrenia treated with clozapine (200-900 mg/day), who gained at least 2.5 kg while on clozapine.

Exclusion criteria

• Patients known to be allergic to aripiprazole
• Hospitalized patients
• Patients who have previously received study medication in an aripiprazole clinical study or who have participated in any clinical trial with an investigational agent within the past month.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups, including a placebo group

A1

Active Comparator group

Treatment:

Drug: aripiprazole

A2

Placebo Comparator group

Treatment:

Drug: Placebo