Specialized Clozapine Clinic for Bipolar and Schizoaffective Disorder

This study has been completed.
Sponsor:
Information provided by:
St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier:
NCT00683709
First received: May 21, 2008
Last updated: August 2, 2011
Last verified: August 2011
  Purpose

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.

Condition Intervention Phase
Bipolar Affective Disorder
Schizoaffective Disorder
Behavioral: Counselling as Usual
Behavioral: CBT
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: 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

Resource links provided by NLM:


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

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: 5 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: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: January 2007
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Counselling as Usual
Discussing Clozapine medication, diet and exercise as per clinical protocol potential weight changes
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.
Cognitive Behavoural Therapy
Counselling about Clozapine medication, diet and exercise in a structured fashion using Cognitive Behavioural Therapy about potential weight changes
Behavioral: 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.

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

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

Locations
Canada, Ontario
St. Joseph's Healthcare, Centre for Mountain Health Services
Hamilton, Ontario, Canada, L8N 3K7
Sponsors and Collaborators
St. Joseph's Healthcare Hamilton
Investigators
Principal Investigator: Gary Hasey, MD St. Joseph's Healthcare and McMaster University, Hamilton
  More Information

No publications provided

Responsible Party: Dr. Gary Hasey, McMaster University
ClinicalTrials.gov Identifier: NCT00683709     History of Changes
Other Study ID Numbers: 06-2726
Study First Received: May 21, 2008
Last Updated: August 2, 2011
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by St. Joseph's Healthcare Hamilton:
Bipolar and Schizoaffective Disorder
Clozapine
Metabolic Side Effects
Diet & Exercise
BMI

Additional relevant MeSH terms:
Bipolar Disorder
Disease
Genetic Diseases, X-Linked
Mood Disorders
Psychotic Disorders
Affective Disorders, Psychotic
Genetic Diseases, Inborn
Mental Disorders
Pathologic Processes
Schizophrenia and Disorders with Psychotic Features
Clozapine
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
GABA Agents
GABA Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 20, 2014