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

The Centre for Addiction and Mental Health (Centre de toxicomanie et de santé mentale) (Canada)0 sites200 target enrollmentJanuary 30, 2007

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: The Centre for Addiction and Mental Health (Centre de toxicomanie et de santé mentale) (Canada)
Enrollment: 200
Status: Completed
Last Updated: 11 years ago

No summary available.

Registry

who.int

Start Date

January 30, 2007

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional

Sex

Female

Sponsor

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

•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.

•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)