CompletedNot Applicable

Prevention of Weight Gain in Early Psychoses

Canada70 participantsStarted 2010-02

Plain-language summary

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.

Who can participate

Age range

14 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Weight

Timeframe: Measured at week 0, 4, 8 and 16

Trial details

NCT IDNCT01075295

SponsorCentre for Addiction and Mental Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-12

View on ClinicalTrials.gov More Schizophreniform Disorder trials