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Specialized Clozapine Clinic for Bipolar and Schizoaffective Disorder

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ClinicalTrials.gov Identifier: NCT00683709
Recruitment Status : Completed
First Posted : May 23, 2008
Last Update Posted : August 3, 2011
Sponsor:
Information provided by:
St. Joseph's Healthcare Hamilton

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.

Condition or disease Intervention/treatment
Bipolar Affective Disorder Schizoaffective Disorder Behavioral: Counselling as Usual Behavioral: CBT

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.

Study Type : Observational
Estimated Enrollment : 48 participants
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
Study Start Date : January 2007
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Clozapine
U.S. FDA Resources

Group/Cohort Intervention/treatment
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.



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dr. Gary Hasey, McMaster University
ClinicalTrials.gov Identifier: NCT00683709     History of Changes
Other Study ID Numbers: 06-2726
First Posted: May 23, 2008    Key Record Dates
Last Update Posted: August 3, 2011
Last Verified: August 2011

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

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