Imipramine Treatment for Patients With Multi-organ Bodily Distress Syndrome (Stress-3)
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ClinicalTrials.gov Identifier: NCT01518634 |
Recruitment Status :
Completed
First Posted : January 26, 2012
Last Update Posted : May 9, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Somatisation Disorder Somatoform Disorders | Drug: Imipramine treatment Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 138 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (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) |
Study Start Date : | January 2012 |
Actual Primary Completion Date : | December 2014 |
Actual Study Completion Date : | December 2016 |

Arm | Intervention/treatment |
---|---|
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. |
- Global Clinical Improvement Scale [ Time Frame: After 13 weeks ]Questionnaire, patient-rated improvement of health since the beginning of the study.
- 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 ]

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Ages Eligible for Study: | 20 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01518634
Denmark | |
Research Clinic for Functional Disorders | |
Aarhus, Denmark, 8000 |
Principal Investigator: | Per k Fink, dr.med | Research Clinic for Functional Disorders, Aarhus University Hospital |
Responsible Party: | University of Aarhus |
ClinicalTrials.gov Identifier: | NCT01518634 |
Other Study ID Numbers: |
2011-004294-87 |
First Posted: | January 26, 2012 Key Record Dates |
Last Update Posted: | May 9, 2017 |
Last Verified: | June 2016 |
Bodily Distress Syndrome Medically unexplained symptoms Functional somatic symptoms Functional somatic syndromes |
Treatment Imipramine Tricyclic antidepressant |
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 |