Actively Recruiting

Phase 4
Age: 18Years - 60Years
All Genders
Healthy Volunteers
NCT06232473

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

Led by Aarhus University Hospital · Updated on 2024-01-30

424

Participants Needed

1

Research Sites

304 weeks

Total Duration

On this page

Sponsors

A

Aarhus University Hospital

Lead Sponsor

C

Central Denmark Region

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of multisystem functional somatic disorder meeting criteria for multiorgan bodily distress syndrome
  • Symptoms present for at least six months before inclusion
  • Multisystem FSD is the main health complaint with stable and well-controlled other illnesses
  • Fluent in Danish and able to participate in an educational program
  • First-time referral for specialized treatment for functional somatic disorder
  • For women of fertile age, use of effective contraception during the trial
  • Men with female partners of fertile age must use condoms during the trial and for at least one week after treatment ends
Not Eligible

You will not qualify if you...

  • Participation in psychotherapy or educational programs for FSD within the past 12 months
  • Current or past diagnosis of mania, bipolar disorder, psychosis, severe agitation, deliria, or psychotic symptoms
  • Moderate to severe depression, anxiety, or other psychiatric disorders diagnosed by SCAN or clinically
  • Affective disorders needing urgent psychiatric medication or monitoring
  • Abuse or addiction to alcohol, substances, or medicine
  • Use of duloxetine for at least 8 weeks in the past 6 months
  • Allergy to study drugs or their ingredients
  • Serious or unstable medical conditions such as stroke, Alzheimer's, heart disease, epilepsy, certain digestive disorders, eye pressure issues, dialysis, bleeding problems, Raynaud's phenomenon, uncontrolled hypertension, prostate problems, urinary retention, or history of anaphylactic shock
  • Severe kidney or liver impairment
  • Sweat gland disorders
  • Current pregnancy or breastfeeding
  • Use of CNS-acting drugs other than allowed painkillers
  • Use of drugs that interact with duloxetine including certain antidepressants, supplements, and others
  • Use of potent CYP1A2 inhibitors
  • Use of monoamine oxidase inhibitors without required treatment-free intervals

AI-Screening

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Trial Site Locations

Total: 1 location

1

Research Cinic for Functional Disorders

Aarhus, Denmark, 8200

Actively Recruiting

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Research Team

L

Lise Gormsen, MD, PhD

CONTACT

C

Cecilia Jespersen, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

TREATMENT

Number of Arms

6

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