Skip to main content
OpenTrials
Completed

NCT Number: NCT00683709

Specialized Clozapine Clinic for 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bipolar Affective Disorder Behavior Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders Motor Activity Psychotic Disorders Schizoaffective Disorder Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Joseph's Healthcare, Centre for Mountain Health Services

Hamilton, Ontario, L8N 3K7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Counselling as Usual

Behavioral

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.

CBT

Behavioral

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

St. Joseph's Healthcare Hamilton

Other

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
May 23, 2008
Registry last updated
Aug 3, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.