Multiorgan Functional somatic disorders (FSD) / bodily disstress syndrome (BDS) MedDRA version: 21.1 Level: LLT Classification code 10041319 Term: Somatization disorder System Organ Class: 100000004873
Conditions
Interventions
Trade Name: Cymbalta
Product Name: Cymbalta
Pharmaceutical Form: Capsule
INN or Proposed INN: Duloxetine
CAS Number: 116539-59-4
Current Sponsor code: 9515
Concentration unit: mg milligram(s)
Concentr
Sponsors
Aarhus University Hospital, The Research Clinic for Functional Disorders and Psychosomatics
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • A diagnosis of multiorgan BDS. • Symptoms have been present for at least 1 year at the time of inclusion. • Multiorgan BDS is the predominant health complaint, i.e., concurrent physical or psychiatric illness is stable and well controlled and symptoms can be separated from BDS symptoms. • No current or previous diagnosis of mania, bipolar disorder, psychosis, severe agitation, imminent deliria or psychotic symptoms. • No alcohol, substance or medicine abuse or addiction. • Age 18-60 years. • Understands and speaks Danish fluently and is able to follow and benefit from an educational program. • First-time referral to specialized treatment for functional disorder. • No participation in psychotherapy or educational programs specifically for FSD within the past 12 months. • Written and verbal informed consent and letter of authority. • No current affective disorder requiring fast initiation or continuation of psychiatric pharmacological treatment or psychiatric monitoring. • No concomitant use of CNS-acting drugs (drugs with pain-modulating or antidepressant properties and others) besides paracetamol and ibuprofen (escape medication in restricted doses). When clinically relevant and safe, the prohibited medication is gradually titrated down at the time of study inclusion, and treatments are discontinued at least 2 weeks before the treatment phase. • No current pregnancy or lactation. • Use of efficient contraception for women in the fertile age (contractive pills, intrauterine device, deposit injections of gestagen, subdermal implant, hormone vaginal ring, or transdermal deposit plaster). • No concomitant use of drugs interacting with or contraindicating duloxetine treatment, i.e., antidepressants, antidiuretics, antihypertensives, and triptanes. • No treatment with duloxetine for a period of at least 8 successive weeks within the past 6 months • No concurrency of the following conditions: uncontrolled hypertension, narrow-angle glaucoma, reduced lever function or hepatic insufficiency, renal disease or severe renal impairment, epilepsy, prostatic hypertrophy, tardive dyskinesia, or suicide risk. • No allergy to study medication or excipients in study medication. • Written and verbal informed consent and letter of authority. 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 212 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • SCAN interview or clinical diagnosis of moderate to severe depression, anxiety and other mental disorders. Referral to relevant treatment options is initiated, and the patient is immediately terminated from the trial. • Risk of suicide: The patient is immediately referred to relevant treatment options, and the patient is immediately terminated from the trial. • Pregnancy and breastfeeding. • The patient wants to leave the trial. • The patient cannot cooperate during the experiment. • Development of serious side effects or allergic reactions/hypersensitivity to the trial drug or any of the inactive substances. • Development of depression or other condition requiring psychiatric treatment: The patient is immediately referred to relevant treatment. • Failure to comply with the trial conditions with regard to taking trial medication and filling in trial questionnaires. • Taking pain and/or antidepressant medication, which is not included in the trial. • The trial staff believe that it is in the patient's best interest to stop. • The trial is stopped. This happens if an unexpectedly large number of unwanted events occur. This will be in collaboration with the authorities.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study aims to investigate the effect an 8-week treatment with 60 mg duloxetine or the active placebo benztropine on patient-rated physical and overall health. Additionally, the study investigates the effect of a brief patient education program compared with enhanced usual care for patients with multiorgan functional somatic disorders /BDS and explores the effect of combinations of these interventions in a factorial design. The study will provide evidence for the effect of the two treatments, alone and in combination, applicable and suitable for the majority of patients with multi-organ functional somatic disorders / BDS. ;Secondary Objective: Not appicable;Primary end point(s): Difference in patient-rated physical health measured by an aggregate score of the SF-36 subscales "physical functioning", "bodily pain" and "vitality" at endpoint (12 weeks-T3). This outcome measures physical health domains usually affected in multiorgan BDS. And - Patient-rated overall health improvement measured by the 5-point Clinical Global Improvement Scale (CGI) at end point (week 12-T3). Patients rate their general health as "much worse", "worse", "unchanged", "better" or "much better" in response to the following question: "How do you consider your health status now compared with when you first came to the clinic?" This simple and global scale correlates with other specific outcomes in this population, including physical functioning and symptom scores. ;Timepoint(s) of evaluation of this end point: Outcome measures are collected at 4 time points: before clinical assessment and inclusion, T0; before treatment, T1; during treatment (after the group session/during drug treatment 6 weeks after inclusion, T2); and at trial endpoint (after completion of the patient education program and/or after 8 weeks of 60 mg of study drug, T3) before tapering out of study drug. Time between inclusion and endpoint will be 12 weeks. Patient-rated follow-up data is collected 3 mon | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Difference between groups at endpoint in: - symptoms of BDS measured by the BDS Checklist and the somatization subscore of the 92-item Danish version of the Symptom Checklist (SCL-92) - symptom intensity, symptom interference, and pain intensity measured by the numeric rating scale - symptoms of anxiety and depression measured by relevant subscores of the Symptom Checklist (SCL-92) - illness worry measured by Whiteley-7 - physical, mental and social health measured by relevant subscales of the Short Form 36 Health Survey (SF-36) and the component summaries Treatment target measures: Difference between groups at endpoint in: - illness perception measured by Brief-IPQ - illness behavior measured by BRIQ - cognitive functioning measured by the Cognitive Failures Questionnaire (CFQ) - psychological Inflexibility in Pain Scale (PIPS) Clinician-rated secondary outcome measures: Clinician-rated improvement measured by the 5-point CGI scale (12 weeks) Clinicians’ rating of biopsychosocial awareness and readiness to change Diagnostic reassessment. Adverse events (manualized patient interview) Other measures: - Patients expectations of treatment effects measured by the Credibility/Expectancy Questionnaire (CEQ) at inclusion and endpoint [44]and, for the patients receiving study drug, expected effect of the study drug on their overall wellbeing (10-point NRS) - Patients' and clinicians' relationship measured by the Working Alliance Inventory-Short revised (WAI-SR)at endpoint. - Negative effects of psychotherapy measured by the Inventory for the Assessment of Negative Effects of Psychotherapy (INEP)at 3-month follow-up. - Health-economic measures: European Quality of Life – 5 dimensions (EQ-D5) and data from Danish National Registries (use of health care (primary and secondary care visits), sick-leave and social benefits, prescriptions) at inclusion and 1- and 2 year-follow-up. - Patients’ recollection of the educational content and impression | — |
Countries
Denmark
Contacts
Public ContactLise Gormsen
Aarhus University Hospital, The Research Clinic for Functional Disorders and Psychosomatics
Outcome results
None listed