Bipolar Affective Disorder, Schizoaffective Disorder
Conditions
Keywords
Bipolar and Schizoaffective Disorder, Clozapine, Metabolic Side Effects, Diet & Exercise, BMI
Brief 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.
Interventions
BEHAVIORALCounselling 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.
BEHAVIORALCBT
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.
Sponsors
St. Joseph's Healthcare Hamilton
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clients diagnosed with bipolar disorder or schizoaffective disorder * Clients who respond poorly to treatment * Males and females ages 18 years or older * Clients who have had a trial of antipsychotics, incl. at least one atypical antipsychotic plus at least 2 mood stabilizers * Clients who are capable of providing informed consent
Exclusion criteria
* Clients who take carbamazepine * Clients with a history of extremely low white blood counts * Clients with severe kidney, liver or heart disease, or heart operation * Clients are hypersensitive to clozapine * Clients who have a history of serious side effects after previous treatment with clozapine * Clients with alcohol or drugs abuse within the last 3 months * Clients who have a seizure disorder * Clients who have metal in the head, neck or eyes, shrapnel, bullets, or body piercing, a pacemaker, brain aneurism clips, cochlear implant, hearing aid, tens unit, spinal implant, or pregnancy. These safety measures are necessary because of the magnetic fields of the MRI scan.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| 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. | 5 years |
Countries
Canada
Outcome results
None listed