Actively Recruiting
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
Eligibility Criteria
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
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
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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