Condition category
Digestive System
Date applied
30/01/2007
Date assigned
30/01/2007
Last edited
17/11/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Brenda B Toner

ORCID ID

Contact details

Social Equity & Health Research
Centre for Addiction & Mental Health
455 Spadina Ave
Suite 300
Toronto
Ontario
M5S 2G8
Canada
+1 416 535 8501 ext. 7607
brenda_toner@camh.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MCT-63138

Study information

Scientific title

Cognitive behavioural therapy and antidepressant treatment in functional bowel disorders: a multicentre randomised, parallel, three arm trial studying behavioural and medication impact

Acronym

Study hypothesis

Combination therapy (cognitive behavioural therapy [CBT] plus desipramine) is superior to monotherapy (CBT or desipramine) for functional bowel disorders in women.

Ethics approval

Centre for Addiction and Mental Health Research Ethics Board (CAMH REB), Toronto Academic Health Sciences Council (TAHSC) (Canada) approved on the 7th March 2006

Study design

Randomised parallel three arm trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Can be found at: http://www.camh.net/Research/Studies_and_recruitment/functional_bowel_study.html

Condition

Functional bowel disorders

Intervention

Group 1: cognitive behaviour therapy (CBT), once a week for 12 weeks
Group 2: desipramine, up to 150 mg/day for 12 weeks
Group 3: combined CBT plus desipramine: CBT once a week and desipramine administered weekly up to 150 mg/day for 12 weeks

Contact for public queries:
Adrienne Amato
Research Co-ordinator
Social Equity & Health Research
Centre for Addiction & Mental Health
455 Spadina Ave, Suite 300
Toronto, Ontario M5S 2G8
Canada
Tel: +1 416 979 4296
Fax: +1 416 979 6811
Email: adrienne_amato@camh.net

Intervention type

Drug

Phase

Not Applicable

Drug names

Desipramine

Primary outcome measures

Composite measure consisting of:
1. Satisfaction with treatment
2. Global well being
3. Pain ratings
4. Health related quality of life

Points two to four above will be measured at pre-treatment, post-treatment, three month follow up and six month follow up.

Secondary outcome measures

Four outcomes of composite measure will be analysed separately as secondary variables:
1. Satisfaction with treatment: post-treatment, three month follow up, six month follow up
2. Global well being: pre-treatment, post-treatment, three month follow up, six month follow up
3. Pain ratings: pre-treatment, end of treatment, three month follow up, six month follow up
4. Health related quality of life: post-treatment, three month follow up, six month follow up

Overall trial start date

01/05/2006

Overall trial end date

31/05/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Literate, female patients aged 18 to 65 years
2. Symptoms present at least two days per week for greater than six months
3. Diagnosis of painful functional bowel disorder (later subcategorised using Rome II Criteria as irritable bowel syndrome [IBS], functional abdominal pain syndrome, painful constipation or unspecified functional bowel disorder [FBD])
4. Moderate (MFBD) or severe (SFBD) functional bowel disorder (FBD) based on the Functional Bowel Disorder Severity Index (FBDSI) that we developed. SFBD is defined as a score more than 110, and MFBD as a score between 36 and 110. Patients with mild symptoms (less than 36) will be excluded, since the proposed treatments would not be cost-effective nor clinically needed.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

200

Participant exclusion criteria

1. No evidence for lactose intolerance explaining the symptoms
2. Absence of heart disease, cardiac arrhythmias, glaucoma, urinary retention, pregnancy, alcohol consumption more than 3 oz/day that would preclude participation or prevent data assessment, or systemic or gastrointestinal diseases or previous surgery that would interfere with the interpretation of symptoms or physiology (active thyroid disease, scleroderma, vasculitis, IBD, ischaemic bowel, gastrointestinal bypass or resection, malabsorption syndromes)
3. No history of bipolar disorder requiring hospitalisation, schizophrenia, substance abuse/dependency, or suicide attempts. Other psychiatric disorders may be excluded if they preclude successful participation in the study.
4. Ability and willingness to discontinue anticholinergic medication, calcium channel blockers or 5-hydroxytryptamine (5HT) receptor acting agents for the duration of the study
5. Discontinuance of all antidepressant medications for at least one month
6. Patients who have previously used Desipramine for more than one week
7. Use of an acceptable method of birth control (birth control pill, condoms, foam and barrier, intrauterine device [IUD], sterilisation) throughout the study (if receiving anti- depressant treatment)

Recruitment start date

01/05/2006

Recruitment end date

31/05/2010

Locations

Countries of recruitment

Canada

Trial participating centre

Social Equity & Health Research
Toronto, Ontario
M5S 2G8
Canada

Sponsor information

Organisation

The Centre for Addiction and Mental Health (Centre de toxicomanie et de santé mentale) (Canada)

Sponsor details

33 Russell Street
Toronto
Ontario
M5S 2S1
Canada

Sponsor type

Hospital/treatment centre

Website

http://www.camh.net/

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-63138)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes