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

Phase 3

Terminated

Conditions: Schizophrenia
Schizoaffective Disorder
Bipolar I Disorder
Metabolic Syndrome

Interventions: Drug: Oanzapine, risperidone, or quetiapine
Drug: Aripiprazole

Registration Number: NCT00857818

Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

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).

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 64

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group (Oanzapine, risperidone, or quetiapine)	Oanzapine, risperidone, or quetiapine	-
Aripiprazole	Aripiprazole	-

Primary Outcome Measures

Name	Time	Method
Mean Baseline Fasting Non-HDL Levels	At baseline (Day 1)
Mean Percent Change From Baseline in Fasting Non-high Density Lipoprotein (Non-HDL) Cholesterol Levels	Baseline to Weeks 4, 8, and 16	Based on Last Observation Carried Forward data. Non-HDL cholesterol is defined as the difference between total cholesterol and high-density lipoprotein (HDL) cholesterol levels. Fasting non-HDL cholesterol is defined as the measured fasting HDL cholesterol level subtracted from the measured fasting total cholesterol level.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and 1 or More AEs	Baseline to Week 16, continuously	AE=any new untoward medical event or worsening of a preexisting medical condition that may or may not be causally related to treatment. SAE=any untoward medical occurrence that at any dose results in death; is life-threatening, a congenital anomaly/birth defect, or an important medical event; requires or prolongs inpatient hospitalization, or results in persistent or significant incapacity or drug dependency or abuse.
Mean Changes in Weight From Baseline	Baseline to Weeks 4, 8, and 16
Mean Changes in Serum Prolactin Levels From Baseline	Baseline to Weeks 4, 8. and 16
Mean Percent Changes From Baseline in Fasting Triglyceride and Total, High-Density Lipoprotein, and Low-Density Lipoprotein Cholesterol Levels	Baseline to Week 16
Mean Changes From Baseline in Fasting Glucose Levels	Baseline to Week 16
Percent of Participants Showing a Decrease or Increase in Body Weight of 7% or Greater From Baseline	Baseline and Weeks 4, 8, and 16
Mean Changes From Baseline in Clinical Global Impression-Severity (CGI-S) Scale	Baseline and Weeks 4, 8, and 16	The CGI-S scale is a 7-point scale that requires the clinician to rate the severity of a patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; or 7=extremely ill.
Number of Participants With Potentially Clinically Relevant Changes From Baseline in Blood Pressure, Heart Rate, Hemoglobin Levels, White Blood Cell Count, Differential Count, and Absolute Platelet Count	Baseline and Weeks 4, 8, and 16	Any value falling outside of the normal range will be flagged for the attention of the investigator at the site. The investigator will indicate whether or not a flagged value is of clinical significance.
Mean Change From Baseline in Impact of Weight on Quality of Life (IWQoL-Lite) Scores	Baseline to Weeks 4, 8, and 16	The IWQoL-Lite is a 31-item self-report survey that assesses the impact of weight on quality of life (QoL) in obese patients. Total score=the sum of scores(ranging from 1-5 for each item) for all 31 items. The sum is then rescaled to a 0-100 scoring, with 0 representing the poorest and 100 the best QoL. The survey also assesses improvements in QoL that occur with weight losses of 5% or greater and deteriorations in QoL with weight gain of 5% or greater. A change of 7.8 to 12.0 points from baseline=meaningful improvement. A change of -4.5 to -7.6 points from baseline=meaningful deterioration.
Median Changes in Body Mass Index From Baseline	Baseline to Weeks 4, 8, and 16