Metabolic Effects of Switching to Aripiprazole in Patients With Bipolar Disorders

Seoul National University

Status and phase: Completed; Phase 4

Conditions: Metabolic Complication; Bipolar Disorders

Treatments: Drug: aripiprazole

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00845988

06-2008-104

Details and patient eligibility

About

The primary goal of this study is to investigate metabolic changes and maintaining efficacy in stabilized patients with bipolar disorders who have pharmacologically induced weight gain.

Full description

• reduced treatment adherence due to metabolic side effects
• suggested advantages of aripiprazole in metabolic profile over other antipsychotics or mood stabilizers
• randomized trial of switch from previous drugs to aripiprazole

Enrollment: 28 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• patients with bipolar disorders (I, II, NOS) diagnosed with DSM-IV criteria
• age between 18 and 65
• Decisional capacity is adequate to provide informed consent or has an authorized appropriate surrogate decision maker. in a syndromal remission state at least for 2 months : CGI - BP ≤ 3
• patients who have exhibited a clinically significant increase in body weight after starting the administration of their current antipsychotic (ie >7% weight gain)

Exclusion criteria

• diagnosis of eating disorder, substance abuse, and psychotic disorder
• history of neurological and medical illness
• pregnant or breast feeding women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

treatment as usual

Active Comparator group

Description:

patients showing weight gain while receiving treatment with risperidone, olanzapine, quetiapine, or clozapine

Treatment:

Drug: aripiprazole

switch to aripiprazole

Experimental group

Description:

aripiprazole

Treatment:

Drug: aripiprazole