NCT06232473 Patient Education and Duloxetine, Alone and in Combination, for Patients With Multisystem Functional Somatic Disorder

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.

This trial targets 424 participants in total. It began in 2024-01-01 with a primary completion date of 2027-11-01.

Brief Summary

The goal of this clinical trial is to test if patient education or duloxetine can be used to treat multisystem functional somatic disorder (FSD). The main questions it aims to answer are: * Does duloxetine work better than placebo in the treatment of FSD? * Does patient education work better than usual treatment for FSD? * Does the combination of patient education and duloxetine work better than using only one of these treatments? Participants are patients with FSD. They will receive one of six different treatment combinations: 1. Patient education alone (three individual consultations with a doctor and one group session) 2. Treatment as usual (receiving the diagnosis and a short presentation of what FSD is) 3. Duloxetine 4. Active placebo (a treatment that looks like duloxetine and has similar side effects, but no known effect on FSD) 5. Patient education and duloxetine 6. Patient education and active placebo Researchers will compare the groups receiving patient education with those receiving only treatment as usual to see if patient education is a better treatment than just receiving a diagnosis and short explanation. Furthermore, researchers will compare the groups receiving duloxetine to those receiving placebo to see if duloxetine works better than placebo. Finally, researchers will compare the groups receiving both patient education and duloxetine to those receiving only one of these treatments to see if the combination works better than the treatments given alone. The researchers will also collect samples of blood and stool in a biobank to be used in future research.

Eligibility 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)

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