Clinical Trials for Somatic Symptom Disorder
There is currently 1 ongoing clinical trial investigating treatments for somatic symptom disorder, a condition characterized by physical symptoms that cannot be fully explained by an underlying medical condition. This trial is evaluating the effectiveness of medication combined with patient education in improving symptoms and quality of life for people living with this condition. (Also known as: Functional Somatic Disorder, Bodily Distress Syndrome)
Clinical trial locations
- Denmark
Study on Duloxetine and Benztropine Mesylate for Patients with Severe Functional Somatic Disorder
This trial is investigating whether medication and patient education can help people with severe functional somatic disorder. The study is being conducted in Denmark and lasts for 13 weeks.
Who can join this trial:
- Adults between 18 and 60 years old
- People diagnosed with a multiorgan functional disorder or Bodily Distress Syndrome (BDS) with symptoms lasting at least 6 months
- Those whose other health conditions (if any) are stable and well-controlled
- Individuals with no history of alcohol, drug, or medication dependency
- People who speak fluent Danish and can participate in an education program
- Those seeking specialized treatment for a functional disorder for the first time
- Individuals who have not participated in psychotherapy or education programs specifically for BDS in the past year
Who cannot join this trial:
- People outside the 18-60 age range
- Those who do not have a diagnosis of functional somatic disorder
- Individuals who belong to vulnerable populations requiring special protection
- Those who do not meet other specific health criteria set by the study organizers
What the trial involves:
The main goal of this study is to understand how effective a patient education program and medication are in treating functional somatic disorder. Participants will be randomly assigned to receive either medication or a placebo (an inactive treatment for comparison), along with participating in an education program designed to help manage symptoms.
Throughout the 13-week period, participants will be monitored using various questionnaires that measure quality of life, overall health improvement, symptoms of anxiety and depression, and physical, mental, and social well-being. The study will also examine biological factors related to functional disorders and conditions involving inflammation.
Investigational drugs:
The trial is testing duloxetine (also known as Cymbalta), which is commonly used to treat depression and anxiety. It works by balancing brain chemicals that affect mood and pain. The medication is given as a 30 mg capsule taken by mouth. The study also mentions benztropine mesylate, though duloxetine is the primary medication being investigated for its potential to improve symptoms in people with functional somatic disorder.
Participants will also take part in a structured patient education program designed to help them understand and manage their symptoms more effectively.
Summary
Currently, there is only one active clinical trial for somatic symptom disorder, and it is being conducted in Denmark. This trial focuses on combining medication treatment with patient education to address the complex nature of this condition. The study is investigating duloxetine, a medication already established for treating depression and anxiety, to see if it can also benefit people with functional somatic disorders. The trial emphasizes a comprehensive approach that includes both medical treatment and patient empowerment through education, reflecting the understanding that this condition involves both physical and psychological components.
