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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

Primary Purpose

Schizophrenia, Schizoaffective Disorder, Bipolar I Disorder

Status
Terminated
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Aripiprazole
Oanzapine, risperidone, or quetiapine
Sponsored by
Otsuka Pharmaceutical Development & Commercialization, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aripiprazole

Control group (Oanzapine, risperidone, or quetiapine)

Arm Description

Outcomes

Primary Outcome Measures

Mean Percent Change From Baseline in Fasting Non-high Density Lipoprotein (Non-HDL) Cholesterol Levels
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.
Mean Baseline Fasting Non-HDL Levels

Secondary Outcome Measures

Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and 1 or More AEs
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 Percent Changes From Baseline in Fasting Triglyceride and Total, High-Density Lipoprotein, and Low-Density Lipoprotein Cholesterol Levels
Mean Changes From Baseline in Fasting Glucose Levels
Percent of Participants Showing a Decrease or Increase in Body Weight of 7% or Greater From Baseline
Mean Changes From Baseline in Clinical Global Impression-Severity (CGI-S) Scale
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
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
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.
Mean Changes in Weight From Baseline
Median Changes in Body Mass Index From Baseline
Mean Changes in Serum Prolactin Levels From Baseline

Full Information

First Posted
March 6, 2009
Last Updated
November 7, 2013
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00857818
Brief Title
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

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Terminated
Why Stopped
Slow Accrual
Study Start Date
April 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder, Bipolar I Disorder, Metabolic Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aripiprazole
Arm Type
Experimental
Arm Title
Control group (Oanzapine, risperidone, or quetiapine)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Other Intervention Name(s)
Abilify, BMS-334039
Intervention Description
Aripiprazole administered orally as tablets, 5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days within a range of 10 to 30 mg daily, for 16 weeks
Intervention Type
Drug
Intervention Name(s)
Oanzapine, risperidone, or quetiapine
Intervention Description
Oanzapine, risperidone, or quetiapine administered orally as tablets at prior dosage for 16 weeks
Primary Outcome Measure Information:
Title
Mean Percent Change From Baseline in Fasting Non-high Density Lipoprotein (Non-HDL) Cholesterol Levels
Description
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.
Time Frame
Baseline to Weeks 4, 8, and 16
Title
Mean Baseline Fasting Non-HDL Levels
Time Frame
At baseline (Day 1)
Secondary Outcome Measure Information:
Title
Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and 1 or More AEs
Description
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.
Time Frame
Baseline to Week 16, continuously
Title
Mean Percent Changes From Baseline in Fasting Triglyceride and Total, High-Density Lipoprotein, and Low-Density Lipoprotein Cholesterol Levels
Time Frame
Baseline to Week 16
Title
Mean Changes From Baseline in Fasting Glucose Levels
Time Frame
Baseline to Week 16
Title
Percent of Participants Showing a Decrease or Increase in Body Weight of 7% or Greater From Baseline
Time Frame
Baseline and Weeks 4, 8, and 16
Title
Mean Changes From Baseline in Clinical Global Impression-Severity (CGI-S) Scale
Description
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.
Time Frame
Baseline and Weeks 4, 8, and 16
Title
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
Description
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.
Time Frame
Baseline and Weeks 4, 8, and 16
Title
Mean Change From Baseline in Impact of Weight on Quality of Life (IWQoL-Lite) Scores
Description
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.
Time Frame
Baseline to Weeks 4, 8, and 16
Title
Mean Changes in Weight From Baseline
Time Frame
Baseline to Weeks 4, 8, and 16
Title
Median Changes in Body Mass Index From Baseline
Time Frame
Baseline to Weeks 4, 8, and 16
Title
Mean Changes in Serum Prolactin Levels From Baseline
Time Frame
Baseline to Weeks 4, 8. and 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
Local Institution
City
Pentincton
State/Province
British Columbia
ZIP/Postal Code
V2A 4M4
Country
Canada
Facility Name
Local Institution
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 2A1
Country
Canada
Facility Name
Local Institution
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3K7
Country
Canada
Facility Name
Local Institution
City
London
State/Province
Ontario
ZIP/Postal Code
N6H 4V1
Country
Canada
Facility Name
Local Institution
City
Markham
State/Province
Ontario
ZIP/Postal Code
L6B 1A1
Country
Canada
Facility Name
Local Institution
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5M 4N4
Country
Canada
Facility Name
Local Institution
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 1R8
Country
Canada
Facility Name
Local Institution
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
Local Institution
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1N 3M5
Country
Canada
Facility Name
Local Institution
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
Facility Name
Local Institution
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3M 3A9
Country
Canada
Facility Name
Local Institution
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4H 1R3
Country
Canada
Facility Name
Local Institution
City
Quebec
ZIP/Postal Code
G1R 2W8
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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