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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
History of Changes

May 21, 2008
August 2, 2011
January 2007
July 2011   (final data collection date for primary outcome 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. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
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 ]
Complete list of historical versions of study NCT00683709 on ClinicalTrials.gov Archive Site
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 ]
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 ]
Not Provided
Not Provided
 
Specialized Clozapine Clinic for Bipolar and Schizoaffective Disorder
Metabolic Side Effects, Diet and Exercise Counseling and Brain Function in a Naturalistic Clinical Trial of Clozapine for Treatment Resistant Bipolar and Schizoaffective Disorder

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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Psychiatric outpatients from within the catchment area of the hospitalwho suffer from chizoaffective disorder and respond poorly to treatment offered to participate in research
  • Bipolar Affective Disorder
  • Schizoaffective Disorder
  • 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.
  • 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.
  • Counselling as Usual
    Discussing Clozapine medication, diet and exercise as per clinical protocol potential weight changes
    Intervention: Behavioral: Counselling as Usual
  • Cognitive Behavoural Therapy
    Counselling about Clozapine medication, diet and exercise in a structured fashion using Cognitive Behavioural Therapy about potential weight changes
    Intervention: Behavioral: CBT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
July 2011
July 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00683709
06-2726
No
Dr. Gary Hasey, McMaster University
St. Joseph's Healthcare Hamilton
Not Provided
Principal Investigator: Gary Hasey, MD St. Joseph's Healthcare and McMaster University, Hamilton
St. Joseph's Healthcare Hamilton
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP