Specialized Clozapine Clinic for Bipolar and Schizoaffective Disorder

Completed

• Conditions: Bipolar Affective Disorder; Schizoaffective Disorder
• Interventions: Behavioral: Counselling as Usual; Behavioral: CBT

• Registration Number: NCT00683709
• Lead Sponsor: St. Joseph's Healthcare Hamilton

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.

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2008-05-21
• Study First Submitted QC: 2008-05-21
• Study First Posted: 2008-05-23
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-02
• Last Update Posted: 2011-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Counselling as Usual	Counselling as Usual	Discussing Clozapine medication, diet and exercise as per clinical protocol potential weight changes
Cognitive Behavoural Therapy	CBT	Counselling about Clozapine medication, diet and exercise in a structured fashion using Cognitive Behavioural Therapy about potential weight changes

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

St. Joseph's Healthcare, Centre for Mountain Health Services; 🇨🇦 Hamilton, Ontario, Canada