Imipramine Treatment for Patients With Multi-organ Bodily Distress Syndrome

NCT01518634 | Completed Phase 2 DMC

• 1 other identifier: 2011-004294-87
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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 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. End point is 13 weeks, i.e. after 10 weeks of 25-75 mg study drug.

Conditions

Somatisation Disorder; Somatoform Disorders

Keywords

Bodily Distress Syndrome; Medically unexplained symptoms; Functional somatic symptoms; Functional somatic syndromes; Treatment; Imipramine; Tricyclic antidepressant

Outcome Measures

Primary Outcomes (1)

• Global Clinical Improvement Scale

  Questionnaire, patient-rated improvement of health since the beginning of the study.

  After 13 weeks

Secondary Outcomes (5)

• SF-36

  At 1 and 13 weeks

• Visual Analogue Scale for pain and worst symptom

  At 1 and 13 weeks

• Symptom Checklist (SCL)

  At 1, 3 and 13 weeks

• Functional Illness Checklist (FIC)

  At 1, 3 and 13 weeks

• WHODAS II

  At 1 and 13 weeks

Study Arms (2)

Imipramine treatment

EXPERIMENTAL

Drug: Imipramine treatment

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Imipramine treatment DRUG

Two-week of wash-out, one week of 10 mg study drug, 10 weeks of 25-75 mg study drug, four weeks of phasing-out and finaly two weeks after ther last dose of study drug to monito adverse events.

Imipramine treatment

Placebo DRUG

Two-week of wash-out, one week of 10 mg study drug, 10 weeks of 25-75 mg study drug, four weeks of phasing-out and finaly two weeks after ther last dose of study drug to monito adverse events.

Placebo

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Research Clinic for Functional Disorders

Aarhus, 8000, Denmark

Location

Related Publications (1)

• Agger JL, Schroder A, Gormsen LK, Jensen JS, Jensen TS, Fink PK. Imipramine versus placebo for multiple functional somatic syndromes (STreSS-3): a double-blind, randomised study. Lancet Psychiatry. 2017 May;4(5):378-388. doi: 10.1016/S2215-0366(17)30126-8. Epub 2017 Apr 10.

  PMID: 28408193 RESULT

MeSH Terms

Conditions

Somatoform Disorders; Medically Unexplained Symptoms

Condition Hierarchy (Ancestors)

Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Per k Fink, dr.med

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2012
• First Posted: January 26, 2012
• Study Start: January 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2016
• Last Updated: May 9, 2017

Record last verified: 2016-06

Locations

DK (1)