Trial Comparing the Effects of Aripiprazole With Those of Standard of Care on Non-HDL Cholesterol in Patients With Schizophrenia or Bipolar I Disorder Who Have Metabolic Syndrome

NCT ID: NCT00857818

Last Updated: 2013-12-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2010-03-31

Brief Summary

The purpose of this study was to determine whether patients with schizophrenia, schizoaffective disorder, or bipolar I disorder who also have metabolic syndrome have a larger decrease in fasting non-high density lipoprotein (non-HDL) cholesterol levels with aripiprazole than with their current atypical antipsychotic treatment (olanzapine, risperidone, or quetiapine).

Conditions

Schizophrenia; Schizoaffective Disorder; Bipolar I Disorder; Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Aripiprazole

Group Type: EXPERIMENTAL

Aripiprazole

Intervention Type: DRUG

Aripiprazole administered orally as tablets, 5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days within a range of 10 to 30 mg daily, for 16 weeks

Control group (Oanzapine, risperidone, or quetiapine)

Group Type: ACTIVE_COMPARATOR

Oanzapine, risperidone, or quetiapine

Intervention Type: DRUG

Oanzapine, risperidone, or quetiapine administered orally as tablets at prior dosage for 16 weeks

Interventions

Aripiprazole

Aripiprazole administered orally as tablets, 5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days within a range of 10 to 30 mg daily, for 16 weeks

Intervention Type: DRUG

Oanzapine, risperidone, or quetiapine

Oanzapine, risperidone, or quetiapine administered orally as tablets at prior dosage for 16 weeks

Intervention Type: DRUG

Other Intervention Names

Abilify; BMS-334039

Eligibility Criteria

Inclusion Criteria

• Competency in understanding nature of study and ability to sign informed consent form
• A clinical diagnosis of schizophrenia, schizoaffective disorder, or bipolar I disorder (manic or mixed) that has been treated with antipsychotics (oral olanzapine, risperidone or quetiapine) for at least 3 months.
• Treatment with any of the antipsychotic medications olanzapine, risperidone, or quetiapine for at least 3 months
• A Clinical Global Impression-Severity Scale score of 4 or lower at baseline
• Confirmed diagnosis of metabolic syndrome
• Patients not receiving treatment specifically for any of the parameters related to metabolic syndrome at the time of randomization
• Women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and up to 4 weeks after last dose of investigational product
• Patients for whom it is clinically appropriate to switch from their current atypical antipsychotic to aripiprazole (determined by the investigator)

Exclusion Criteria

• Risk of suicide (suicidal ideation or recently attempted suicide)
• Meeting Diagnostic and Statistical Manual of Mental Disorders, 4th ed, text revision criteria for any significant psychoactive substance use disorder within 3 months of screening
• Diagnosis of type 1 or 2 diabetes mellitus
• Current treatment for 1 of the components of metabolic syndrome
• Use of medication for the purpose of weight loss
• Diagnosis of bipolar disorders other than bipolar 1, depression with psychotic symptoms, or organic brain syndromes
• History of neuroleptic malignant syndrome
• Diagnosis of Parkinson's disease, Alzheimer's disease, multiple sclerosis, cerebral palsy, epilepsy, or mental retardation
• History of seizures
• Abnormal blood count for platelets, hemoglobin, absolute neutrophils, aspartate aminotransferase, alanine aminotransferase, creatinine, fasting glucose, and thyroid-stimulating hormone
• Electrocardiogram recording with QTc interval >475 msec
• Detectable levels of cocaine or positive screen for stimulants or other drugs considered (determined by the investigator) to be of abuse or dependence
• Blood alcohol levels superior or equal to 50 mg/dL [or 10.9 mmol/L]
• Prior participation in an aripiprazole clinical trial
• Treatment with aripiprazole within 1 month of enrollment
• Predefined exclusionary laboratory tests
• Patients with Bipolar Disorder treated with adjunctive therapy other than a stable dose of mood stabilizers (lithium or valproate) must undergo a 30-day washout period for adjunctive therapies, such as antidepressants, prior to randomization.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Bristol-Myers Squibb

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Local Institution

Calgary, Alberta, Canada

Local Institution

Pentincton, British Columbia, Canada

Local Institution

Vancouver, British Columbia, Canada

Local Institution

Hamilton, Ontario, Canada

Local Institution

London, Ontario, Canada

Local Institution

Markham, Ontario, Canada

Local Institution

Mississauga, Ontario, Canada

Local Institution

Toronto, Ontario, Canada

Local Institution

Toronto, Ontario, Canada

Local Institution

Montreal, Quebec, Canada

Local Institution

Montreal, Quebec, Canada

Local Institution

Montreal, Quebec, Canada

Local Institution

Montreal, Quebec, Canada

Local Institution

Québec, Quebec, Canada

Countries

Canada

Related Links

http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

Other Identifiers

CN138-564

Identifier Type: -

Identifier Source: org_study_id