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Study on Duloxetine and Benztropine Mesylate for Patients with Severe Functional Somatic Disorder

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as Functional Somatic Disorder, which involves physical symptoms that cannot be fully explained by any underlying medical condition. The study aims to explore the effects of a patient education program and the use of medications on this disorder. The medications being tested include Cymbalta (duloxetine), which is commonly used to treat depression and anxiety, and Benztropine Mesylate, which is often used to treat symptoms of Parkinson's disease. Additionally, a placebo will be used for comparison purposes.

The purpose of the study is to investigate the effectiveness of the patient education program and to examine biological factors related to functional disorders and diseases where inflammation plays a significant role. Participants will be randomly assigned to receive either the medication or a placebo, along with the education program. The study will last for a period of 13 weeks, during which participants will be monitored for changes in their health and well-being.

Throughout the study, participants will be asked to assess their health-related quality of life and overall improvement using various questionnaires. The study will also look at symptoms of anxiety and depression, as well as physical, mental, and social well-being. The results will help determine the impact of the treatment on the participants' health and provide insights into the management of Functional Somatic Disorder.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be informed about the trial's objectives and procedures. The study aims to explore the effects of a patient education program and the biological factors in functional disorders.

  2. Step 2

    Medication administration

    The patient will receive either Cymbalta (duloxetine) or a placebo. Cymbalta is administered as a 30 mg hard gastro-resistant capsule taken orally. The exact dosage and frequency will be determined by the study protocol.

  3. Step 3

    Patient education program

    The patient will participate in a structured education program designed to help understand and manage symptoms associated with functional somatic disorders.

  4. Step 4

    Monitoring and assessments

    Throughout the trial, the patient's health-related quality of life and functional ability will be assessed using various scales, including the SF-36 and the Clinical Global Improvement Scale (CGI).

    Additional assessments will measure symptoms of anxiety, depression, and other relevant health indicators.

  5. Step 5

    End of trial evaluation

    At the end of the trial, the patient's overall health improvement will be evaluated. This includes a comparison of health status from the beginning to the end of the study period.

Who can join the trial?

7 criteria

  • Age between 18 and 60 years.
  • Have a diagnosis of a **multiorgan Functional Disorder** or **Bodily Distress Syndrome (BDS)** with symptoms lasting at least 6 months at the time of joining the study. A **multiorgan Functional Disorder** means that symptoms affect more than one part of the body.
  • Any other physical or mental health condition must be stable and well-controlled, and the symptoms should be distinguishable from BDS symptoms.
  • No misuse or dependency on alcohol, drugs, or medication.
  • Must understand and speak fluent Danish and be able to follow and benefit from a patient education program.
  • First-time referral for specialized treatment of a functional disorder.
  • No participation in psychotherapy or patient education programs specifically for BDS in the last 12 months.

Who cannot join the trial?

4 criteria

  • Individuals who are not within the specified age range for the study.
  • Individuals who do not have the specific medical condition being studied, which is a **Functional Somatic disorder**. This refers to physical symptoms that cannot be fully explained by a medical condition.
  • Individuals who are part of a vulnerable population, meaning groups that might need special protection or care.
  • Individuals who do not meet other specific health criteria set by the study organizers.
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Investigated drugs

Duloxetine is a medication used in this trial to help patients with severe functional disorders. It is commonly used to treat depression and anxiety, and it works by balancing chemicals in the brain that affect mood and pain. In this study, it is being tested to see if it can improve symptoms in patients with these disorders.

What is already known about the treatment

Duloxetine – Duloxetine is typically administered orally in the form of capsules. It is currently well-established in medical literature as a treatment for various conditions, including depression and anxiety disorders. In this clinical trial, it is being investigated for its potential benefits in treating functional somatic disorders. Duloxetine works by increasing the levels of serotonin and norepinephrine in the brain, which helps improve mood and reduce pain perception. It is classified as a serotonin-norepinephrine reuptake inhibitor (SNRI).

Investigated diseases

Functional Somatic Disorder – This condition involves experiencing physical symptoms that cannot be fully explained by any underlying medical or neurological condition. Individuals with this disorder often report a variety of symptoms such as pain, fatigue, and digestive issues, which can affect multiple organ systems. The symptoms are real and can significantly impact daily functioning and quality of life. The disorder progresses with fluctuating symptoms that may vary in intensity and duration. It is often associated with stress and emotional factors, which can exacerbate the symptoms. The condition requires a comprehensive approach to understand the interplay between physical and psychological aspects.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514264-42-00Estimated enrolment212 patientsSponsorRegion Midtjylland

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