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: 14.0 Level: HLT Classification code 10041326 Term: Somatoform disorders System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: Imipramin "DAK" 25 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: IMIPRAMINE
CAS Number: 50-49-7
Concentration unit: mg milligram(s)
Concentration type: equal
Pharmaceutical form of t
Sponsors
Per Klausen Fink
Eligibility
Sex/Gender
All
Inclusion criteria
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: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 somatisation 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.;Secondary Objective: Secondary aim is to show wheter Imipramine has effect both on painful symptoms and other symptoms of Bodily Distress Syndrome, measured by Visual Analogue Scale (VAS) and Functional Illness Checklist (Fic).;Primary end point(s): Primary end point is patient-rated improvement measured by Clinical Global Improvement Scale (CGI-I). ;Timepoint(s) of evaluation of this end point: Clinical Global Improvement Scale (CGI-I) is rated by the patient after 10 weeks of sufficient dosage study medication (minimum 25 mg). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary end point is functional level (physical, mental and social) measured by the SF-36, and symptom characterization measured by Visual Analogue Scale (VAS) og Functional Illness Checklist (Fic).;Timepoint(s) of evaluation of this end point: SF-36 questionnaire is given to the patient before inclusion and after 10 weeks of sufficient dosage study medication (minimum 25 mg). Visual Analogue Scale (VAS) og Functional Illness Checklist (Fic) is filled out before inclusion, at treatment start and after 10 weeks of sufficient dosage study medication (minimum 25 mg). | — |
Countries
Denmark
Contacts
Public ContactClinical Trial Information
Research Clinic for Functional Disorders and Psychosomatics
Outcome results
None listed