Schizophreniform DisorderNCT01075295
Prevention of Weight Gain in Early Psychoses
A study testing Behavioural Intervention for the Prevention of Weight Gain and TAU in people with Schizophreniform Disorder and Bipolar I Disorder, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 45 years
- Conditions the study is for
- Schizophreniform Disorder, Bipolar I Disorder, Bipolar II Disorder
- What is being tested?
- Behavioural Intervention for the Prevention of Weight Gain and TAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2010to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Schizophreniform Disorder, Bipolar I Disorder, Bipolar II Disorder, Major Depressive Disorder, Substance-Induced Psychoses, Psychosis Not Otherwise Specified
- Being tested
- Behavioural Intervention for the Prevention of Weight Gain, TAU
- Keywords
- Schizophreniform Disorder, Schizophrenia, Schizoaffective disorder, Bipolar I Disorder, Bipolar II Disorder, Major Depressive Disorder with Psychotic Features,, Substance-Induced Psychoses, Psychosis Not Otherwise Specified, antipsychotic, weight gain, body mass index, BMI, waist circumference, WC, coronary heart disease, CHD
- Medical subject headings
- Psychotic Disorders, Bipolar Disorder, Depressive Disorder, Major, Psychoses, Substance-Induced, Schizophrenia, Weight Gain, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioural Intervention for the Prevention of Weight GainBehavioural
The intervention consists of four steps:
- STEP 1 (Watchful Waiting): Measurement of body weight and Waist Circumference at the start (1 visit). Subjects that have a weight gain greater then or equal to 2% of their baseline weight will progress to Step 2
- STEP 2 (Self monitoring): Self-monitoring of daily weight, daily food intake \& physical activity (1 visit) Subjects that have a weight gain greater then or equal to 2% (from STEP 2) will progress to Step 3
- STEP 3 (Nutrition \& Exercise Counseling): Counseling for nutrition and physical activity (4 visits; 2 in-clinic, 2 telephone) Subjects that have a weight gain greater then or equal to 2% (from STEP 3) will progress to Step 4
- STEP 4 (Intensive): Intensive behavioral training geared towards reducing caloric intake (4 in-clinic visits)
TAUOther
Treatment as provided by individuals' existing healthcare providers
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Intervention | Experimental | Not described Receives: Behavioral: Behavioural Intervention for the Prevention of Weight Gain |
| TAU | Active comparator | Not described Receives: Other: TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
The proportion with an increase in weight (2% or greater), from baseline to end point.
Measured: Measured at week 0, 4, 8 and 16
Secondary outcomes (1)
Laboratory parameters
- Fasting glucose
- Insulin
- Lipids
Measured: Measured at week 0 and 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophreniform DisorderStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Rohan Ganguli, Centre for Addiction and Mental Health
- Investigators
- Rohan Ganguli, MD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01075295
- Sponsor's protocol ID
- 133/2009
- Status last verified
- Jul 2017
- First submitted
- 23 Feb 2010
- Last updated
- 25 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Weight Gain in Early Psychoses
- ClinicalTrials.gov ID
- NCT01075295
- Acronym / sponsor ID
- 133/2009
- Conditions
- Schizophreniform Disorder, Bipolar I Disorder, Bipolar II Disorder, Major Depressive Disorder, Substance-Induced Psychoses, Psychosis Not Otherwise Specified
- Keywords
- Schizophreniform Disorder, Schizophrenia, Schizoaffective disorder, Bipolar I Disorder, Bipolar II Disorder, Major Depressive Disorder with Psychotic Features,, Substance-Induced Psychoses, Psychosis Not Otherwise Specified, antipsychotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Feb 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 25 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Intervention | Experimental | Behavioral: Behavioural Intervention for the Prevention of Weight Gain |
| TAU | Active comparator | Other: TAU |
Who may qualify
- Ages
- 14 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioural Intervention for the Prevention of Weight GainThe intervention consists of four steps: * STEP 1 (Watchful Waiting): Measurement of body weight and Waist Circumference at the start (1 visit). Subjects that have a weight gain greater then or equal to 2% of their baseline weight will progress to Step 2 * STEP 2 (Self monitoring): Self-monitoring of daily weight, daily food intake \& physical activity (1 visit) Subjects that have a weight gain greater then or equal to 2% (from STEP 2) will progress to Step 3 * STEP 3 (Nutrition \& Exercise Counseling): Counseling for nutrition and physical activity (4 visits; 2 in-clinic, 2 telephone) Subjects that have a weight gain greater then or equal to 2% (from STEP 3) will progress to Step 4 * STEP 4 (Intensive): Intensive behavioral training geared towards reducing caloric intake (4 in-clinic visits) | Behavioural | Lifestyle Intervention |
| TAUTreatment as provided by individuals' existing healthcare providers | Other | TAU |
Primary outcome
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.
1 secondary outcome
Laboratory parameters
Time frame: Measured at week 0 and 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2017.
- Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital. It is fully affiliated with the University of Toronto, and is a PAHO/WHO Collaborating Centre.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rohan Ganguli, MD principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioural Intervention for the Prevention of Weight Gain and TAU in people with Schizophreniform Disorder and Bipolar I Disorder, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: Measured at week 0, 4, 8 and 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2017.