Specialized Clozapine Clinic for Bipolar and Schizoaffective Disorder

Schizoaffective Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00683709
• Other study ID #: 06-2726
• 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

Related Conditions & MeSH terms

• Bipolar Affective Disorder
• Bipolar Disorder
• Disease
• Genetic Diseases, X-Linked
• Mood Disorders
• Psychotic Disorders
• Schizoaffective Disorder

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