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Specialized Clozapine Clinic for Bipolar and Schizoaffective Disorder

NCT00683709 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 48

Last updated 2011-08-03

No results posted yet for this study

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.

Conditions

  • Bipolar Affective Disorder
  • Schizoaffective Disorder

Interventions

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.

Sponsors & Collaborators

  • St. Joseph's Healthcare Hamilton

    lead OTHER

Principal Investigators

  • Gary Hasey, MD · St. Joseph's Healthcare and McMaster University, Hamilton

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00683709 on ClinicalTrials.gov