Imipramine Treatment for Patients With Multi-organ Bodily Distress Syndrome
Information source: University of Aarhus
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Somatisation Disorder; Somatoform Disorders
Intervention: Imipramine treatment (Drug); Placebo (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: University of Aarhus Official(s) and/or principal investigator(s): Per k Fink, dr.med, Principal Investigator, Affiliation: Research Clinic for Functional Disorders, Aarhus University Hospital
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 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.
Clinical Details
Official title: Treatment of Multi-organ Bodily Distress Syndrome. A Double-blinded Placebo Controlled Trial of the Effects of Imipramine (Stress-3)
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Global Clinical Improvement Scale
Secondary outcome: SF-36Visual Analogue Scale for pain and worst symptom Symptom Checklist (SCL) Functional Illness Checklist (FIC) WHODAS II
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.
Eligibility
Minimum age: 20 Years.
Maximum age: 50 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. First time refered patients fulfilling diagnostic criteria for BDS multi-organ type
with symptoms for more than 3 of 4 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 have Danish parents. The patient understands, speaks, writes and
read Danish.
Exclusion Criteria:
1. Presence og other physical of psychiatric condition, if the symptoms of this
condition can not clearly be separated from symptoms of BDS
2. 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.
3. A lifetime-diagnosis of psychoses, 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 patches,
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. 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
10. 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
Locations and Contacts
Research Clinic for Functional Disorders, Aarhus 8000, Denmark
Additional Information
Starting date: January 2012
Last updated: January 13, 2015
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