Specialized Clozapine Clinic for Bipolar and Schizoaffective Disorder

St. Joseph's Healthcare Hamilton

Status

Completed

Conditions

Schizoaffective Disorder

Bipolar Affective Disorder

Treatments

Behavioral: Counselling as Usual

Behavioral: CBT

Study type

Observational

Funder types

Other

Identifiers

NCT00683709

06-2726

Details and patient eligibility

About

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.

Full 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.

Enrollment

48 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.