Status:
COMPLETED
Imipramine Treatment for Patients With Multi-organ Bodily Distress Syndrome
Lead Sponsor:
University of Aarhus
Conditions:
Somatisation Disorder
Somatoform Disorders
Eligibility:
All Genders
20-50 years
Phase:
PHASE2
Brief Summary
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 dis...
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 condition...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT01518634
Start Date
January 1 2012
End Date
December 1 2016
Last Update
May 9 2017
Active Locations (1)
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1
Research Clinic for Functional Disorders
Aarhus, Denmark, 8000