Trials / Completed
CompletedNCT00683709
Specialized Clozapine Clinic for Bipolar and Schizoaffective Disorder
Metabolic Side Effects, Diet and Exercise Counseling and Brain Function in a Naturalistic Clinical Trial of Clozapine for Treatment Resistant Bipolar and Schizoaffective Disorder
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 48 (estimated)
- Sponsor
- St. Joseph's Healthcare Hamilton · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| BEHAVIORAL | CBT | 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. |
Timeline
- Start date
- 2007-01-01
- Primary completion
- 2011-07-01
- Completion
- 2011-07-01
- First posted
- 2008-05-23
- Last updated
- 2011-08-03
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT00683709. Inclusion in this directory is not an endorsement.