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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

Tracking Information
First Submitted Date May 21, 2008
First Posted Date May 23, 2008
Last Update Posted Date August 3, 2011
Study Start Date January 2007
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 24, 2011)
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 ]
Original Primary Outcome Measures
 (submitted: May 21, 2008)
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 ]
Change History Complete list of historical versions of study NCT00683709 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 24, 2011)
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 ]
Original Secondary Outcome Measures
 (submitted: May 21, 2008)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Specialized Clozapine Clinic for Bipolar and Schizoaffective Disorder
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
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Bipolar Affective Disorder
  • 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.
  • 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.
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: May 21, 2008)
48
Original Estimated Enrollment Same as current
Actual Study Completion Date July 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT00683709
Other Study ID Numbers 06-2726
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr. Gary Hasey, McMaster University
Study Sponsor St. Joseph's Healthcare Hamilton
Collaborators Not Provided
Investigators
Principal Investigator: Gary Hasey, MD St. Joseph's Healthcare and McMaster University, Hamilton
PRS Account St. Joseph's Healthcare Hamilton
Verification Date August 2011