Imipramine Treatment for Patients With Multi-organ Bodily Distress Syndrome (Stress-3)
The aim of this study is to test the effect of the tricyclic antidepressant Imipramine in patients with longlasting health problems with no known medical explanation, defined as multi-organ Bodily distress syndrome (BDS). Pharmacological treatment of patients with BDS have never been tested, and Imipramine i low dosage (10-75 mg) has the potential of reducing both pain and other symptoms of bodily distress for patients with BDS. Control conditions are pill placebo. Study duration is 19 weeks for each of the 140 patients.
Drug: Imipramine treatment
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Treatment of Multi-organ Bodily Distress Syndrome. A Double-blinded Placebo Controlled Trial of the Effects of Imipramine (Stress-3)|
- Global Clinical Improvement Scale [ Time Frame: After 13 weeks ] [ Designated as safety issue: No ]Questionnaire, patient-rated improvement of health since the beginning of the study.
- SF-36 [ Time Frame: At 1 and 13 weeks ] [ Designated as safety issue: No ]Questionnaire, patient-rated. Assessment of physical, social and mental functioning
- Visual Analogue Scale for pain and worst symptom [ Time Frame: At 1 and 13 weeks ] [ Designated as safety issue: No ]
- Symptom Checklist (SCL) [ Time Frame: At 1, 3 and 13 weeks ] [ Designated as safety issue: No ]
- Functional Illness Checklist (FIC) [ Time Frame: At 1, 3 and 13 weeks ] [ Designated as safety issue: No ]
- WHODAS II [ Time Frame: At 1 and 13 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
|Experimental: Imipramine treatment||
Drug: Imipramine treatment
Dosages is 10-75 mg Imipramine/placebo tablets pr. day in a period of 12-19 weeks.
|Placebo Comparator: Placebo||
placebo tablets pr. day in a period of 12-19 weeks.
The aim of this study is to test the effect of Imipramine in patients with multi-organ Bodily distress syndrome (BDS). BDS is a unifying diagnosis that encompasses a group of closely related conditions such as somatization disorder, fibromyalgia, irritable bowel syndrome and chronic fatigue syndrome. The project consists of a double-blinded placebo controlled trial of treatment with the tricyclic antidepressant Imipramine in dosages of 25-75 mg. Primary outcome is patient-rated improvement measured by Clinical Global Improvement Scale (CGI-I). Secondary outcome is functional level (physical, mental and social) measured by the SF-36 Physical Component Summary (PCS). The study requires 140 participants and study duration is 19 weeks for each patient.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01518634
|Contact: Per K Fink, email@example.com|
|Contact: Johanne L Agger, M.Dfirstname.lastname@example.org|
|Research Clinic for Functional Disorders||Recruiting|
|Aarhus, Denmark, 8000|
|Principal Investigator: Per K Fink, dr.med|
|Sub-Investigator: Johanne L Agger, MD|
|Principal Investigator:||Per k Fink, dr.med||Research Clinic for Functional Disorders, Aarhus University Hospital|