Treatment of patients with long-lasting health problems (chronic functional disorders) with Imipramine

Phase 1

• Conditions: F 45 Somatisation disorder and related disorders.Bodily distress syndrome is a new diagnosis that resembles F 45 Somatisation disorder, but with a more specific set of diagnostic criteria.; MedDRA version: 14.0Level: HLTClassification code 10041326Term: Somatoform disordersSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]

• Registration Number: EUCTR2011-004294-87-DK
• Lead Sponsor: Per Klausen Fink

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-10-25
• Study Completion: 2015-05-01
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 138

Inclusion Criteria

1. Functional disorder defined as Bodily Distress Syndrome multi organ type with symptoms from at least three out of four symptom categories
2. Moderate or severe impact on daily life
3. Symptoms lasting for at least 2 years
4. Age 20-50 years
5. Born in Denmark or by Danish parents. The patients must understand, speak, write and read Danish.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 140
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria
1. Presence of other physical or mental illness if it is not possible to separate the symptoms of this illness from the symptoms of BDS
2. Current major or moderate depressive disorder, continuous treatment because of this, other severe psychiatric disorder that demands treatment, or suicidal thoughts
3. A lifetime diagnosis of psychosis, mania or depression with psychotic symptoms (ICD-10: F20-29, F30-31, F32.3, F33.3)
4. Abuse of alcohol, narcotics, or drugs
5. Pregnancy, breastfeeding or current pregnancy wish. Fertile women must use effective anticonception, (hormonal contraception, contraceptive injection, implant or patch, intrauterine system and device, vaginal ring).
6. 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.
7. Imipramine treatment in sufficient dosage within the last year, i.e. 25 mg daily continuously for at least 8 weeks.
8. Allergy to study medication or excipients in study medication.
9. 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
10. Simultaneous use of:
- antipsychotics
- oral anticoagulantia
- diuretics
- sympatomimetica and CNS-stimulating drugs (amphetamine-like drugs)
- all serotonergic drugs, e.g. SSRI, SNRI and TCA, the dietary supplement pericum (hypericum perforatum), monoamine oxidase (MAO) inhibitors, triptans, tramadol, petidin and tryptofan
- the drugs cimetidin (H2-antagonist), quinidin (antiarrythmica), cclonidin (antihypertensive), fluconazol (antimycotica), clindamycin, clarithromycin, erythromycin (antibiotic), droperidol (anaesthetic), levodopa (antiparkinson), mefloquin (antimalaria), phenytoin, barbiturates, carbamazepin (antiepilepitica), hydroxizin (antihistamine), buspiron (anxiolytica)
- Bupropion (tobacco dependence), celecoxib (NSAID), cinacalcet (antiparatyroidea drug), duloxetine (SNRI), flufenazin (antipsychotic), fluoxetine (SSRI), gefitinib (antineoplastic), moclobemid (MAO), paroxetin, sertralin (SSRI), terbinafin (antimycotica), yohimbine (erectil dysfunction) and fluvoxamin (SSRI), ciprofloxacin and enoxacin (microbiotic), because plasma concentration of imipramine can increase with simultaneous use of these potent CYP2D6- and CYP1A2- inhibitors.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified