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Imipramine Treatment for Patients With Multi-organ Bodily Distress Syndrome (Stress-3)
This study has been completed.
Sponsor:
University of Aarhus
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01518634
First received: January 13, 2012
Last updated: May 8, 2017
Last verified: June 2016
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Purpose
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. End point is 13 weeks, i.e. after 10 weeks of 25-75 mg study drug.
| Condition | Intervention | Phase |
|---|---|---|
| Somatisation Disorder Somatoform Disorders | Drug: Imipramine treatment Drug: Placebo | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Participant, Care Provider, 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) |
Resource links provided by NLM:
Further study details as provided by University of Aarhus:
Primary Outcome Measures:
- Global Clinical Improvement Scale [ Time Frame: After 13 weeks ]Questionnaire, patient-rated improvement of health since the beginning of the study.
Secondary Outcome Measures:
- SF-36 [ Time Frame: At 1 and 13 weeks ]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 ]
- Symptom Checklist (SCL) [ Time Frame: At 1, 3 and 13 weeks ]
- Functional Illness Checklist (FIC) [ Time Frame: At 1, 3 and 13 weeks ]
- WHODAS II [ Time Frame: At 1 and 13 weeks ]
| Enrollment: | 138 |
| Study Start Date: | January 2012 |
| Study Completion Date: | December 2016 |
| Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Imipramine treatment |
Drug: Imipramine treatment
Two-week of wash-out, one week of 10 mg study drug, 10 weeks of 25-75 mg study drug, four weeks of phasing-out and finaly two weeks after ther last dose of study drug to monito adverse events.
|
| Placebo Comparator: Placebo |
Drug: Placebo
Two-week of wash-out, one week of 10 mg study drug, 10 weeks of 25-75 mg study drug, four weeks of phasing-out and finaly two weeks after ther last dose of study drug to monito adverse events.
|
Detailed Description:
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. End point is 13 weeks, i.e. after 10 weeks of 25-75 mg study drug.
Eligibility| Ages Eligible for Study: | 20 Years to 50 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- First time refered patients fulfilling diagnostic criteria for BDS multi-organ type with symptoms for more than 3 of 4 symptom categories
- Moderate or severe impact on daily life
- Symptoms lasting for at least 2 years
- Age 20-50 years
- Born in Denmark or have Danish parents. The patient understands, speaks, writes and read Danish.
Exclusion Criteria:
- Presence og other physical of psychiatric condition, if the symptoms of this condition can not clearly be separated from symptoms of BDS
- Current moderate or severe depression, patients in continuous antidepressant treatment because of moderate or severe depression, and patients with other severe psychiatric disorder that demands treatment, or if the patient is suicidal.
- A lifetime-diagnosis of psychoses, mania or depression with psychotic symptoms (ICD-10: F20-29, F30-31, F32.3, F33.3)
- Abuse of alcohol, narcotics or drugs
- Pregnancy, breastfeeding or current pregnancy wish. Fertile women must use effective anticonception, (hormonal contraception, contraceptive injection, implant or patches, intrauterine system and device, vaginal ring).
- Treatment with all pain modulating drugs, e.g. all analgesics, antidepressants, antiepileptica and other types of medication with pain relieving properties must be discontinued at least two weeks before the treatment phase.
- Imipramine treatment in sufficient dosage within the last year, i.e. 25 mg daily continuously for at least 8 weeks.
- Allergy to study medication or excipients in study medication.
- Patients with previous med myocardial infarction, congestive heart failure, signs of conduction defects or abnormalities on ECG (first degree AV-block, bundle branch block or prolonged QT-interval), narrow-angle glaucoma, porphyria, inherited galactose intolerance, epilepsy, hepatic insufficiency and severe renal impairment
-
Simultaneous use of:
- antipsychotics
- oral anticoagulants
- diuretics
- sympathomimetics and CNS-stimulating drugs (amphetamine-like drugs)
- all serotonergic drugs, e.g. SSRI, SNRI and TCA, the dietary supplement hypericum perforatum, non-selective, irreversible or selective, reversible monoamine oxidase (MAO) inhibitors, triptans, tramadol, pethidin and tryptophan
- the drugs cimetidine (H2-antagonist), quinidine (antiarrythmics), clonidine (antihypertensive), fluconazol (antimycotics), clindamycin, clarithromycin, erythromycin (antibiotics), droperidol (anaesthetic), levodopa (antiparkinson), mefloquine (antimalaria), phenytoin, barbiturates, carbamazepin (antiepileptica)
- Bupropion (tobacco dependence), celecoxib (NSAID), cinacalcet (antiparathyroid drug), duloxetine (SNRI), flufenazin (antipsychotic), fluoxetin (SSRI), gefitinib (antineoplastic), moclobemid (MAO), paroxetine, Sertraline (SSRI), Terbinafine (antimycotics), Yohimbin (erectile dysfunction) samt fluvoxamin (SSRI), ciprofloxacin and enoxacin (microbiotic), because plasma concentration of Imipramine can increase with the simultaneous use of these potent CYP2D6- and CYP1A2- inhibitors
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01518634
Please refer to this study by its ClinicalTrials.gov identifier: NCT01518634
Locations
| Denmark | |
| Research Clinic for Functional Disorders | |
| Aarhus, Denmark, 8000 | |
Sponsors and Collaborators
University of Aarhus
Investigators
| Principal Investigator: | Per k Fink, dr.med | Research Clinic for Functional Disorders, Aarhus University Hospital |
More Information
Publications:
| Responsible Party: | University of Aarhus |
| ClinicalTrials.gov Identifier: | NCT01518634 History of Changes |
| Other Study ID Numbers: |
2011-004294-87 |
| Study First Received: | January 13, 2012 |
| Last Updated: | May 8, 2017 |
Keywords provided by University of Aarhus:
|
Bodily Distress Syndrome Medically unexplained symptoms Functional somatic symptoms Functional somatic syndromes |
Treatment Imipramine Tricyclic antidepressant |
Additional relevant MeSH terms:
|
Disease Syndrome Somatoform Disorders Pathologic Processes Mental Disorders Imipramine Antidepressive Agents, Tricyclic Antidepressive Agents |
Psychotropic Drugs Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Adrenergic Agents Neurotransmitter Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on July 21, 2017