An observational study in Bipolar Affective Disorder and Schizoaffective Disorder, sponsored by St. Joseph's Healthcare Hamilton. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-08-03.
Sponsored by St. Joseph's Healthcare Hamilton · Observational
Bipolar Disorder (BD) and Schizoaffective Disorder (SA) clients.
To determine whether the changes in BMI produced in subjects with Bipolar Disorder (BD) and Schizoaffective Disorder (SA) by 12 months of treatment with clozapine, can be diminished after an intense and highly structured intervention focused on diet and exercise, compared with the usual brief counseling regarding weight gain on this drug.
1,626 studies on the registry are indexed under Psychotic Disorders; 293 are open to participants now.
This study's planned enrollment of 48 is below the median of 150 across 245 observational studies indexed under Psychotic Disorders.
Browse Psychotic Disorders studies →St. Joseph's Healthcare Hamilton is the lead sponsor of 137 studies on the registry; 31 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Psychiatric outpatients from within the catchment area of the hospitalwho suffer from chizoaffective disorder and respond poorly to treatment offered to participate in research
Exclusion Criteria:
Discussing Clozapine medication, diet and exercise as per clinical protocol potential weight changes
Behavioral: Counselling as Usual
Counselling about Clozapine medication, diet and exercise in a structured fashion using Cognitive Behavioural Therapy about potential weight changes
Behavioral: CBT
5 - 20 minutes, about the effects of clozapine on body weight, appetite, blood sugar and fats such as cholesterol and triglycerides in the blood, and how these might affect your health in the future.
45 - 60 minutes individual treatment sessions focused on nutrition, exercise and weight control and will occur weekly for 4 weeks. After this, 10 group sessions focused on weight reduction will be held every 2 weeks. This will be followed by 6 group sessions focused on weight maintenance held every 2 weeks.
Increases in BMI in subjects with BD and SA after 12 months of clozapine treatment will be smaller in subjects treated with CBT ex/diet compared with those receiving CAU.
Time frame: 5 years
Adverse changes in plasma lipids, blood sugar, and fitness level will be greater in subjects treated with CBT ex/diet compared with those receiving CAU after 12 months of clozapine treatment.
Time frame: 5 years
This study is completed, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.
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St. Joseph's Healthcare Hamilton