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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00683709
Other study ID # 06-2726
Secondary ID
Status Completed
Phase Phase 4
First received May 21, 2008
Last updated August 2, 2011
Start date January 2007
Est. completion date July 2011

Study information

Verified date August 2011
Source St. Joseph's Healthcare Hamilton
Contact n/a
Is FDA regulated No
Health authority Canada: Canadian Institutes of Health Research
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Intervention

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.
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.

Locations

Country Name City State
Canada St. Joseph's Healthcare, Centre for Mountain Health Services Hamilton Ontario

Sponsors (1)

Lead Sponsor Collaborator
St. Joseph's Healthcare Hamilton

Country where clinical trial is conducted

Canada, 

Outcome

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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