Specialized Clozapine Clinic for Bipolar and Schizoaffective Disorder
|ClinicalTrials.gov Identifier: NCT00683709|
Recruitment Status : Completed
First Posted : May 23, 2008
Last Update Posted : August 3, 2011
Bipolar Disorder (BD) and Schizoaffective Disorder (SA) clients.
- determine if after 12 months of treatment with clozapine, the BMI changes with clients who are councelled as usual regarding weight gain while on Clozapine.
- determine if after 12 months of treatment with clozapine, the BMI changes with intense, structured councelling about diet and exercise.
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Affective Disorder Schizoaffective Disorder||Behavioral: Counselling as Usual Behavioral: CBT||Phase 4|
|Study Type :||Observational|
|Estimated Enrollment :||48 participants|
|Official Title:||Metabolic Side Effects, Diet and Exercise Counseling and Brain Function in a Naturalistic Clinical Trial of Clozapine for Treatment Resistant Bipolar and Schizoaffective Disorder|
|Study Start Date :||January 2007|
|Primary Completion Date :||July 2011|
|Study Completion Date :||July 2011|
Counselling as Usual
Discussing Clozapine medication, diet and exercise as per clinical protocol potential weight changes
Behavioral: Counselling as Usual
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.
Cognitive Behavoural Therapy
Counselling about Clozapine medication, diet and exercise in a structured fashion using Cognitive Behavioural Therapy about potential weight changes
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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00683709
|St. Joseph's Healthcare, Centre for Mountain Health Services|
|Hamilton, Ontario, Canada, L8N 3K7|
|Principal Investigator:||Gary Hasey, MD||St. Joseph's Healthcare and McMaster University, Hamilton|