Imipramine Treatment for Patients With Multi-organ Bodily Distress Syndrome (Stress-3)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University of Aarhus
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01518634
First received: January 13, 2012
Last updated: January 11, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Somatisation Disorder
Somatoform Disorders
Drug: Imipramine treatment
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Global Clinical Improvement Scale [ Time Frame: After 13 weeks ] [ Designated as safety issue: No ]
    Questionnaire, patient-rated improvement of health since the beginning of the study.


Secondary Outcome Measures:
  • SF-36 [ Time Frame: At 1 and 13 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Symptom Checklist (SCL) [ Time Frame: At 1, 3 and 13 weeks ] [ Designated as safety issue: No ]
  • Functional Illness Checklist (FIC) [ Time Frame: At 1, 3 and 13 weeks ] [ Designated as safety issue: No ]
  • WHODAS II [ Time Frame: At 1 and 13 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Imipramine treatment Drug: Imipramine treatment
Dosages is 10-75 mg Imipramine/placebo tablets pr. day in a period of 12-19 weeks.
Placebo Comparator: Placebo Drug: Placebo
placebo tablets pr. day in a period of 12-19 weeks.

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

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01518634

Contacts
Contact: Per K Fink, dr.med +4578464310 per.fink@aarhus.rm.dk
Contact: Johanne L Agger, M.D +4578464344 johanne.agger@aarhus.rm.dk

Locations
Denmark
Research Clinic for Functional Disorders Recruiting
Aarhus, Denmark, 8000
Principal Investigator: Per K Fink, dr.med         
Sub-Investigator: Johanne L Agger, MD         
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Per k Fink, dr.med Research Clinic for Functional Disorders, Aarhus University Hospital
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01518634     History of Changes
Other Study ID Numbers: 2011-004294-87
Study First Received: January 13, 2012
Last Updated: January 11, 2013
Health Authority: Denmark: Danish Medicines Agency
Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by University of Aarhus:
Bodily Distress Syndrome
Medically unexplained symptoms
Functional somatic symptoms
Functional somatic syndromes
Treatment
Imipramine
Tricyclic antidepressant

Additional relevant MeSH terms:
Somatoform Disorders
Mental Disorders
Antidepressive Agents, Tricyclic
Imipramine
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 20, 2014