- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01075295
Prevention of Weight Gain in Early Psychoses
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The rates of obesity and related co-morbidities are several-fold higher in patients with psychosis than in the general population. In addition the life expectancy 20% shorter. Several lifestyle and illness-related factors have been implicated for these high rates, including weight gain associated with treatment with novel antipsychotics. The most important cause of death in psychosis patients is coronary heart disease (CHD), of which obesity is a major risk factor. As well, diabetes and its associated complications occur at high rates in persons with psychosis, and diabetes is both related to obesity and is an independent risk factor for CVD and mortality. It therefore seems reasonable to assume that prevention of obesity may lead to a reduced risk for CVD and diabetes. If the proposed intervention proves successful in preventing weight gain and reducing risk for CVD and diabetes, the quality and length of life for persons with psychosis will be vastly improved and medical costs reduced.
Specifically, we hypothesize that : 1a) a smaller proportion of those in the intervention will gain weight (2% or more) as compared to those receiving usual care, 1b) the mean weight gain of those randomized to the intervention will be less than the mean weight gain in those randomized to usual care 2) Increases in Body Mass Index (BMI) and waist circumference (WC) will be smaller in the intervention group as compared to the controls. 3) there will be smaller increases in cholesterol, triglycerides, blood glucose and insulin levels in the intervention group than in the control group. Exploratory analyses of changes in makers for systemic inflammation, and their relationship to weight, and lipid changes, will be conducted to develop novel hypotheses regarding mediators of CVD risk in psychosis.
The study will recruit sixty persons or outpatients with DSM-lV Psychosis with a BMI of < 30 kg/m², who have been treated for less than 2 years (Early SZ) and meet the other enrollment criteria. They will be randomly assigned in the allocation ratio 1:1 to either get a stepped behavioural intervention for prevention of weight gain (n=30) or treatment as usual (routine care, n=30). This will be a pragmatic clinical trial of 16-week duration.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
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Toronto, Ontario, Canada, M5T 1R8
- Centre for Addiction and Mental Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age between 14 and 45 years (inclusive)
- Male or Female gender
- DSM-IV-TR diagnosis of Schizophrenia, Schizoaffective disorder,Schizophreniform Disorder, Bipolar Disorder (Type I),Bipolar Disorder (Type II), Major Depressive Disorder With Psychotic Features, Substance-Induced Psychoses, Psychosis Not-Otherwise-Specified (NOS)
- Outpatient status at the time of randomization
- Duration of antipsychotic treatment of less than 5 years
- Ability to provide informed consent
- Female patients of childbearing potential must be using a medically accepted means of contraception
- Treatment with olanzapine, clozapine, quetiapine,risperidone or paliperidone for less than 8 weeks duration at enrollment
- BMI between 18.5 and 30
Exclusion Criteria:
- Inability to give informed consent
- Currently enrolled in a weight management program
- Currently being treated with a medication to reduce weight
- Patients with unstable or active cardiovascular illnesses (myocardial infarction, congestive heart failure, etc), active or end-stage renal disease, and unstable thyroid disease, etc
Inclusion/exclusion criteria has been intentionally limited in order to maximize the generalizability of the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lifestyle Intervention
|
The intervention consists of four steps:
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Active Comparator: TAU
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Treatment as provided by individuals' existing healthcare providers
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight
Time Frame: Measured at week 0, 4, 8 and 16
|
The proportion with an increase in weight (2% or greater), from baseline to end point.
|
Measured at week 0, 4, 8 and 16
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Laboratory parameters
Time Frame: Measured at week 0 and 16
|
|
Measured at week 0 and 16
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Rohan Ganguli, MD, Centre for Addiction and Mental Health
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- body mass index
- Schizophreniform Disorder
- Bipolar I Disorder
- CHD
- BMI
- Bipolar II Disorder
- antipsychotic
- weight gain
- coronary heart disease
- waist circumference
- Psychosis Not Otherwise Specified
- Schizophrenia, Schizoaffective disorder
- Major Depressive Disorder with Psychotic Features,
- Substance-Induced Psychoses
- WC
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Chemically-Induced Disorders
- Pathologic Processes
- Substance-Related Disorders
- Mood Disorders
- Body Weight
- Schizophrenia Spectrum and Other Psychotic Disorders
- Body Weight Changes
- Poisoning
- Depression
- Depressive Disorder
- Schizophrenia
- Disease
- Psychotic Disorders
- Mental Disorders
- Depressive Disorder, Major
- Weight Gain
- Shared Paranoid Disorder
- Psychoses, Substance-Induced
Other Study ID Numbers
- 133/2009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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