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

• Status: Terminated
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Treatments: Aripiprazole; Quetiapine Fumarate; Risperidone

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.