NCT00683709

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2008

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

August 3, 2011

Status Verified

August 1, 2011

Enrollment Period

4.5 years

First QC Date

May 21, 2008

Last Update Submit

August 2, 2011

Conditions

Bipolar Affective DisorderSchizoaffective Disorder

Keywords

Bipolar and Schizoaffective DisorderClozapineMetabolic Side EffectsDiet & ExerciseBMI

Outcome Measures

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.

    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.

    5 years

Study Arms (2)

Counselling as Usual

Discussing Clozapine medication, diet and exercise as per clinical protocol potential weight changes

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

Behavioral: CBT

Interventions

Counselling as UsualBEHAVIORAL

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.

Counselling as Usual
CBTBEHAVIORAL

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.

Cognitive Behavoural Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Hamilton, Ontario, L8N 3K7, Canada

Location

MeSH Terms

Conditions

Bipolar DisorderPsychotic DisordersMotor Activity

Interventions

Counseling

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersSchizophrenia Spectrum and Other Psychotic DisordersBehavior

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Gary Hasey, MD

    St. Joseph's Healthcare and McMaster University, Hamilton

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 21, 2008

First Posted

May 23, 2008

Study Start

January 1, 2007

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

August 3, 2011

Record last verified: 2011-08

Locations

CA(1)