Specialized Clozapine Clinic for Bipolar and Schizoaffective Disorder - Full Text View

Sponsored by:	St. Joseph's Healthcare
Information provided by:	St. Joseph's Healthcare
ClinicalTrials.gov Identifier:	NCT00683709

Purpose

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.

Condition	Intervention	Phase
Bipolar Affective Disorder Schizoaffective Disorder	Behavioral: Counseling as usual Behavioral: Intensive counseling	Phase IV

MedlinePlus related topics: Bipolar Disorder Diets Exercise and Physical Fitness

Drug Information available for: Clozapine

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
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

Further study details as provided by St. Joseph's Healthcare:

Primary Outcome Measures:

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. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	48
Study Start Date:	January 2007

Groups/Cohorts	Assigned Interventions
1 Group 1 receives Counseling as Usual regarding diet and exercise	Behavioral: Counseling 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.
2 Group 2 receives Intensive Cognitive Behaviour Therapy Counseling regarding diet and exercise	Behavioral: Intensive counseling 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00683709

Contacts

Contact: Gary Hasey, MD	905-522-1155 ext 35448	ghasey@sympatico.ca
Contact: Rose Marie Mueller, RN	905-522-1155 ext 36629	rmueller@stjoes.ca

Locations

Canada, Ontario
St. Joseph's Healthcare, Centre for Mountain Health Services	Recruiting
Hamilton, Ontario, Canada, L8N 3K7
Principal Investigator: Gary Hasey, MD

Sponsors and Collaborators

St. Joseph's Healthcare

Investigators

Principal Investigator:

Gary Hasey, MD

St. Joseph's Healthcare and McMaster University, Hamilton

More Information

No publications provided

Responsible Party:	McMaster University ( Dr. Gary Hasey )
Study ID Numbers:	06-2726
Study First Received:	May 21, 2008
Last Updated:	May 21, 2008
ClinicalTrials.gov Identifier:	NCT00683709 History of Changes
Health Authority:	Canada: Canadian Institutes of Health Research

Keywords provided by St. Joseph's Healthcare:

Bipolar and Schizoaffective Disorder
Clozapine
Metabolic Side Effects
Diet & Exercise
BMI

Study placed in the following topic categories:

Neurotransmitter Agents
Tranquilizing Agents
Bipolar Disorder
Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Serotonin

Schizophrenia
Affective Disorders, Psychotic
Mental Disorders
Clozapine
Mood Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Disease
Molecular Mechanisms of Pharmacological Action
Bipolar Disorder
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Pharmacologic Actions
GABA Antagonists
Affective Disorders, Psychotic

Serotonin Antagonists
Pathologic Processes
Serotonin Agents
Mental Disorders
Therapeutic Uses
Clozapine
Mood Disorders
GABA Agents
Psychotic Disorders
Central Nervous System Agents
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on May 07, 2009