Clinical trial NCT00857818: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Schizophrenia
Schizoaffective Disorder
Bipolar I Disorder
Metabolic Syndrome
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2009-03-09
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Mean Percent Change From Baseline in Fasting Non-high Density Lipoprotein (Non-HDL) Cholesterol Levels
timeFrame: Baseline to Weeks 4, 8, and 16
measure: Mean Baseline Fasting Non-HDL Levels
timeFrame: At baseline (Day 1)
Secondary outcomes:
measure: Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and 1 or More AEs
timeFrame: Baseline to Week 16, continuously
measure: Mean Percent Changes From Baseline in Fasting Triglyceride and Total, High-Density Lipoprotein, and Low-Density Lipoprotein Cholesterol Levels
timeFrame: Baseline to Week 16
measure: Mean Changes From Baseline in Fasting Glucose Levels
timeFrame: Baseline to Week 16
measure: Percent of Participants Showing a Decrease or Increase in Body Weight of 7% or Greater From Baseline
timeFrame: Baseline and Weeks 4, 8, and 16
measure: Mean Changes From Baseline in Clinical Global Impression-Severity (CGI-S) Scale
timeFrame: Baseline and Weeks 4, 8, and 16
measure: 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
timeFrame: Baseline and Weeks 4, 8, and 16
measure: Mean Change From Baseline in Impact of Weight on Quality of Life (IWQoL-Lite) Scores
timeFrame: Baseline to Weeks 4, 8, and 16
measure: Mean Changes in Weight From Baseline
timeFrame: Baseline to Weeks 4, 8, and 16
measure: Median Changes in Body Mass Index From Baseline
timeFrame: Baseline to Weeks 4, 8, and 16
measure: Mean Changes in Serum Prolactin Levels From Baseline
timeFrame: Baseline to Weeks 4, 8. and 16
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Local Institution
state: Alberta
city: Pentincton
country: Canada
facility: Local Institution
state: British Columbia
city: Vancouver
country: Canada
facility: Local Institution
state: British Columbia
city: Hamilton
country: Canada
facility: Local Institution
state: Ontario
city: London
country: Canada
facility: Local Institution
state: Ontario
city: Markham
country: Canada
facility: Local Institution
state: Ontario
city: Mississauga
country: Canada
facility: Local Institution
state: Ontario
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Quebec
country: Canada
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: