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Functional Disorder clinical trials

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NCT ID: NCT06232473 Recruiting - Functional Disorder Clinical Trials

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

EDULOX
Start date: January 1, 2024
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT04935307 Enrolling by invitation - Clinical trials for Bodily Distress Syndrome

Central Processing of Odour Stimuli in Patients With Functional Somatic Disorder or MCS Compared to Healthy Controls

Start date: March 23, 2021
Phase: N/A
Study type: Interventional

Background: Functional somatic disorders (FSD) are frequent in all medical settings and characterized by persistent physical symptoms that cannot be explained by other somatic or psychiatric conditions. In recent decades, a number of different types of functional somatic disorders have been defined, but so far there is no clear explanation for the pathophysiology. The high prevalence of olfactory problems in some patients with FSD suggests that olfactory symptoms are a potential diagnostic biomarker, especially in patients with multiple chemical sensitivity (MCS). The olfactory system is a unique sense with direct pathways to the limbic system, which is associated with emotion and mood. The focus on the olfactory system has revealed a significant association of this sense with numerous diseases. Hypotheses: - Patients with MCS and FSD have normal olfactory tests (normosmic subjects according to TDI score using "sniffing test") but differ in habituation test compared to healthy controls. - MCS and FSD patients have different odour perception processing in the brain as a "fingerprint" of functional somatic disorder compared to healthy controls. Research plan: The aim of this parts of the study is to identify specific MRI and paraclinical measures for MCS and BDS. In the first phase, 5 patients with MCS and 5 healthy controls will have a full clinical test of the olfactory system at the Flavour Institute, AU. In addition, they will be scanned (for "fingerprinting") where the investigators expect to find changes in olfactory connectivity similar to those seen in depression. This phase of the study will lead to a conclusion on the exact MR parameters to be used in the main study. In the second phase of the study, 10 patients with MCS, 10 with FSD, and 10 healthy controls will be evaluated using a test battery of questionnaires and paraclinical tests. Perspectives: Previous imaging studies have focused on pain stimulation paradigms, rest-state fMRI, and DTI, but the olfactory system may be the "missing link" in identifiying a quantitative candidate in terms of whole-brain computational modeling and could potentially be used as a "fingerprint" in diagnosis and treatment monitoring.

NCT ID: NCT04464447 Completed - Functional Disorder Clinical Trials

Feasibility and Pilot Testing of Group-based ACT for Adolescents With Functional Somatic Syndromes

AHEAD
Start date: May 29, 2013
Phase: N/A
Study type: Interventional

Recurrent and impairing functional somatic syndromes (FSS) are common in adolescents. Despite a high need for care, empirically supported treatments are lacking for youth. The aim of the uncontrolled was to assess feasibility and treatment potential of group-based Acceptance and Commitment Therapy (ACT) in a generic treatment approach for adolescents with multiple FSS i.e. "ACT for Health in Adolescents" (AHEAD).

NCT ID: NCT03694769 Completed - Functional Disorder Clinical Trials

Investigating Drop Attacks

Start date: July 20, 2018
Phase:
Study type: Observational

The aim of this project is to better understand the experiences of people who have idiopathic drop attacks. These falls have no identified medical cause but can cause people injuries such as bruising, facial injuries and, in some cases, broken bones. It can also make them worry about having more falls, and the pain and embarrassment this would cause, and stop them from going out. There has been very little research in this area and there are currently no treatments. In this study, ten people who experience idiopathic drop attacks will be interviewed at an outpatient clinic to understand more about them and the falls. They will be asked in particular about the period of time around when they started having the falls and whether there are aware of any triggers. Participants will also be asked to write accounts of these drop attacks, after they have happened, for a period of eight weeks. They will be asked to describe what they were thinking and feeling, and how they felt in themselves before and after the fall. This information will allow the researcher to look at common experiences that people who experience these falls have. This understanding could help to identify whether a psychological approach to treatment could help individuals to manage and cope with this condition.