Clinical trial NCT00683709: Specialized Clozapine Clinic for Bipolar and Schizoaffective Disorder
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bipolar Affective Disorder
Schizoaffective Disorder
Keywords: Bipolar and Schizoaffective Disorder
Clozapine
Metabolic Side Effects
Diet & Exercise
BMI
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
First posted: 2008-05-23
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Psychiatric outpatients from within the catchment area of the hospitalwho suffer from chizoaffective disorder and respond poorly to treatment offered to participate in research

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 5 years
Secondary outcomes:
measure: 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.
timeFrame: 5 years
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare, Centre for Mountain Health Services
state: Ontario
Study officials:
affiliation: St. Joseph's Healthcare and McMaster University, Hamilton
name: Gary Hasey, MD
role: PRINCIPAL_INVESTIGATOR
References: