Using patient education and duloxetine to treat multisystem functional somatic disorder
Efficacy of Patient Education and Duloxetine, Alone or in Combination, for Patients With Multisystem Functional Somatic Disorder
This study is testing if combining patient education with the medication duloxetine can help people with multisystem functional somatic disorder feel better compared to other treatments.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 424 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Locations | 1 site (Aarhus) |
| Trial ID | NCT06232473 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of patient education and duloxetine in treating multisystem functional somatic disorder (FSD). Participants will be assigned to one of six treatment groups, including patient education alone, duloxetine, and combinations of both. The study will compare the outcomes of these treatments against a placebo and usual care to determine which approach yields the best results for managing FSD symptoms. The trial seeks to provide insights into the role of education in enhancing treatment efficacy for patients with complex, medically unexplained symptoms.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with multisystem functional somatic disorder who have experienced symptoms for at least six months.
Not a fit: Patients with unstable concurrent physical or psychiatric illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide new treatment options that effectively alleviate symptoms for patients suffering from multisystem functional somatic disorder.
How similar studies have performed: While evidence on treatment options for multisystem FSD is emerging, the specific combination of patient education and duloxetine has not been extensively tested, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria for the parent trial: * A diagnosis of multisystem functional somatic disorder (operationalized as fulfilling the criteria for the research diagnosis multiorgan bodily distress syndrome) * Symptoms present for at least six months at the time of inclusion * Multisystem functional somatic disorder 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 * Understands and speaks Danish fluently and is able to follow and benefit from an educational program * First-time referral to specialized treatment for functional somatic disorder Additional inclusion criteria for the nested study drug trial: * 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) * Men with a pregnant or non-pregnant female partner in the fertile age must use a condom in the full length of the trial plus a minimum of one week after end of study drug treatment Exclusion criteria for parent trial: * Participation in psychotherapy or educational programs specifically for FSD within the past 12 months * Current or previous diagnosis of mania, bipolar disorder, psychosis, severe agitation, imminent deliria or psychotic symptoms * SCAN or clinical diagnosis of moderate to severe depression, anxiety or other psychiatric disorders * Current affective disorder requiring fast initiation or continuation of psychiatric pharmacological treatment or psychiatric monitoring * Alcohol, substance or medicine abuse or addiction Additional exclusion criteria for the nested trial * Treatment with duloxetine for a period of at least 8 successive weeks within the past 6 months * Allergy to study medication or excipients in study medication * Serious or unstabile somatic illness, e.g. stroke, Alzheimers disease, ischemic heart disease, epilepsy, fructose intolerance, glucosegalactose malabsorption, invertase-isomaltase insufficiency, increased intraocular pressure, uncontrolled narrow-angle glaucoma, hemodialysis, hemophilia, reduced platelet function, increased bleeding tendency, Raynaud's phenomenon, uncontrolled hypertension, prostate hypertrophy, urin retension or previous anaphylactic shock * Severe renal impairment with creatinine clearance \<30 ml / min. (risk of increased plasma concentration of duloxetine) * Liver disease with reduced function with affected blood tests (risk of increased plasma concentration of duloxetine) * Sweat gland disorder (risk of hyperthermia in high temperatures related to use of benztropine) * Current pregnancy or lactation * 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 study drug treatment begins) * Concomitant use of drugs interacting with or contraindicating duloxetine treatment, e.g. serotonergic antidepressants (SSRI og TCA præparater, e.g. clomipramine or amitriptyline), dietary supplement St. John's wort (Hypericum perforatum), venlafaxine, MAO inhibitants or triptanes, tramadol, pethidin and tryptophan (risik of serotonin syndrome) * Concomitant use of potent CYP1A2-inhibitants, e.g. fluvoxamine, ciprofloxacine og enoxacine (risk of increased plasma concentration of duloxetine) * Concomitant use of non-selective, irreversible or selective, reversible monoaminoxidase (MAO) inhibitants; at least 14 days between termination of treatment with MAO-inhibitants and beginning of treatment with duloxetine. Additionally, treatment with MAO-inhibitants are not allowed before duloxetine treatment has been terminated for 5 days (risk of serotonin syndrome)
Where this trial is running
Aarhus
- Research Cinic for Functional Disorders — Aarhus, Denmark (Recruiting)
Study contacts
- Principal investigator: Lise K Gormsen, MD, PhD — Department of Funtional disorders, Aarhus University Hospital
- Study coordinator: Lise Gormsen, MD, PhD
- Email: lisgorm@rm.dk
- Phone: +4578464310
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.