Metabolic Effects of Switching to Aripiprazole in Patients With Bipolar Disorders

NCT00845988 | Completed Phase 4 DMC

• 1 other identifier: 06-2008-104
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bipolar Disorders; Metabolic Complication

Keywords

Bipolar disorder; metabolic complication; Aripiprazole; Weight gain; Clinical Trial; Antipsychotic; Metabolic syndrome; Psychopharmacology; Open Label

Outcome Measures

Primary Outcomes (1)

• Weight BMI Glucose and lipid profiles CGI-BP KOQOL SWN-K

  0, 4, 8, 12, 18, 26 week

Secondary Outcomes (1)

• ECG prolactin SAS BAS UKU-SERS-Pat-Korean version

  0, 4, 8, 12, 18, 26 week

Study Arms (2)

treatment as usual

ACTIVE COMPARATOR

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

Drug: aripiprazole

switch to aripiprazole

EXPERIMENTAL

aripiprazole

Drug: aripiprazole

Interventions

aripiprazole DRUG

dosage form : po recommended dosage : more than 10mg/day duration : 28 weeks

switch to aripiprazole; treatment as usual

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Korea Otsuka Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Conditions

Bipolar Disorder; Weight Gain; Metabolic Syndrome

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Kyooseob Ha, MD, PhD

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 14, 2009
• First Posted: February 18, 2009
• Study Start: December 1, 2008
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: December 5, 2013

Record last verified: 2013-12

Locations

KR (1)