NCT00857818TerminatedPhase 3
A 16-Week, Randomized, Controlled Trial of the Effect of Aripiprazole Versus Standard of Care on Non-HDL Cholesterol Among Patients With Schizophrenia and Bipolar I Disorder Who Have Pre-existing Metabolic Syndrome
Otsuka Pharmaceutical Development & Commercialization, Inc.1 site in 1 country64 target enrollmentStarted: April 2009Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Mean Baseline Fasting Non-HDL Levels
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Aripiprazole
Experimental
Intervention: Aripiprazole (Drug)
Control group (Oanzapine, risperidone, or quetiapine)
Active Comparator
Intervention: Oanzapine, risperidone, or quetiapine (Drug)
Outcomes
Primary Outcomes
Mean Baseline Fasting Non-HDL Levels
Time Frame: At baseline (Day 1)
Mean Percent Change From Baseline in Fasting Non-high Density Lipoprotein (Non-HDL) Cholesterol Levels
Time Frame: 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 Outcomes
- 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)
- 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)
- 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)
- Mean Change From Baseline in Impact of Weight on Quality of Life (IWQoL-Lite) Scores(Baseline to Weeks 4, 8, and 16)
- Median Changes in Body Mass Index From Baseline(Baseline to Weeks 4, 8, and 16)
Investigators
Study Sites (1)
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