Specialized Clozapine Clinic for Bipolar and Schizoaffective Disorder
NCT ID: NCT00683709
Last Updated: 2011-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
48 participants
OBSERVATIONAL
2007-01-31
2011-07-31
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Counselling as Usual
Discussing Clozapine medication, diet and exercise as per clinical protocol potential weight changes
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
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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St. Joseph's Healthcare Hamilton
OTHER
Responsible Party
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McMaster University
Principal Investigators
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Gary Hasey, MD
Role: PRINCIPAL_INVESTIGATOR
St. Joseph's Healthcare and McMaster University, Hamilton
Locations
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St. Joseph's Healthcare, Centre for Mountain Health Services
Hamilton, Ontario, Canada
Countries
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Other Identifiers
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06-2726
Identifier Type: -
Identifier Source: org_study_id
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