Schizoaffective Disorder Clinical Trial
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
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.
Status | Completed |
Enrollment | 48 |
Est. completion date | July 2011 |
Est. primary completion date | July 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Canada | St. Joseph's Healthcare, Centre for Mountain Health Services | Hamilton | Ontario |
Lead Sponsor | Collaborator |
---|---|
St. Joseph's Healthcare Hamilton |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | |
Secondary | 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 | No |
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