Prevention of Weight Gain in Early Psychoses
Prevention of Weight Gain in Early Psychoses
The purpose of this study is to determine whether individuals with psychotic spectrum
 disorders ( 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)randomly assigned
 to a stepped behavioral intervention for the prevention of weight gain will experience less
 weight gain than individuals who receive usual care. There are several studies that have
 examined the effect of pharmacological and non-pharmacological behavioural approaches for
 weight loss in patients with psychosis, however studies examining strategies for prevention
 of obesity are lacking. This study is an important and novel approach to studying the problem
 of obesity in those with psychosis.
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.
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.