Bipolar Affective DisorderNCT00683709
Specialized Clozapine Clinic for Bipolar and Schizoaffective Disorder
An observational study of Bipolar Affective Disorder and Schizoaffective Disorder, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Affective Disorder, Schizoaffective Disorder
- What is being tested?
- Counselling as Usual and CBT
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2007to Jul 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
St. Joseph's Healthcare, Centre for Mountain Health Services
Hamilton, Ontario, L8N 3K7
About this study
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
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.
Read the 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.
- Being tested
- Counselling as Usual, CBT
- Keywords
- Bipolar and Schizoaffective Disorder, Clozapine, Metabolic Side Effects, Diet & Exercise, BMI
- Medical subject headings
- Bipolar Disorder, Psychotic Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Counselling as UsualBehavioural
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.
CBTBehavioural
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 group | Role | What they receive |
|---|---|---|
| Counselling as Usual | Discussing Clozapine medication, diet and exercise as per clinical protocol potential weight changes Receives: 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 Receives: Behavioral: CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2008 (estimated)
- Study startJan 2007
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar Affective DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Investigators
- Gary Hasey, MD, Principal investigator, St. Joseph's Healthcare and McMaster University, Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00683709
- Sponsor's protocol ID
- 06-2726
- Status last verified
- Aug 2011
- First submitted
- 21 May 2008
- Last updated
- 3 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00683709
- Acronym / sponsor ID
- 06-2726
- Keywords
- Bipolar and Schizoaffective Disorder, Clozapine, Metabolic Side Effects, Diet & Exercise, BMI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 23 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Counselling as Usual | – | Behavioral: Counselling as UsualDiscussing Clozapine medication, diet and exercise as per clinical protocol potential weight changes |
| Cognitive Behavoural Therapy | – | Behavioral: CBTCounselling about Clozapine medication, diet and exercise in a structured fashion using Cognitive Behavioural Therapy about potential weight changes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Counselling as Usual5 - 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. | Behavioural | Counselling as Usual |
| CBT45 - 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. | Behavioural | Cognitive Behavoural Therapy |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary Hasey, MD principal investigator
St. Joseph's Healthcare and McMaster University, Hamilton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Affective Disorder and Schizoaffective Disorder, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2011.