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

Otsuka

Status and phase

Terminated

Phase 3

Conditions

Bipolar I Disorder

Schizophrenia

Schizoaffective Disorder

Metabolic Syndrome

Treatments

Drug: Oanzapine, risperidone, or quetiapine

Drug: Aripiprazole

Study type

Interventional

Funder types

Industry

Identifiers

NCT00857818

CN138-564

Details and patient eligibility

About

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).

Enrollment

64 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.