Understanding how serotonin affects impulsivity in Tourette Disorder
Involvement of the Serotonergic System in the Control of Impulsivity in Tourette Disorder.
This study is testing how serotonin affects impulsivity in people with Tourette Disorder who are being treated with aripiprazole.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 2 sites (Bron and 1 other locations) |
| Trial ID | NCT05942716 on ClinicalTrials.gov |
What this trial studies
This study investigates the role of serotonin in regulating impulsivity among individuals diagnosed with Tourette Disorder. It focuses on the serotonergic system, particularly the 5-HT2A receptor, to understand its influence on both cognitive and affective symptoms associated with the disorder. Participants will receive a PET radiotracer to assess serotonin receptor binding while undergoing neuroimaging. The study aims to explore the relationship between serotonin levels and impulsivity in Tourette patients currently treated with aripiprazole.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 diagnosed with Tourette Disorder who are currently scheduled to receive aripiprazole.
Not a fit: Patients with serious uncontrolled psychiatric comorbidities or those taking drugs with serotonergic effects may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for managing impulsivity in Tourette Disorder.
How similar studies have performed: While the role of dopamine in Tourette Disorder has been extensively studied, the investigation of serotonin's impact is less explored, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
* Inclusion Criteria \* : * Male or Female * Diagnosed with a Tourette Disorder following the DSM-5 * Age between 18-65 years * Member of a social security scheme in France * Freely-given informed consent to participate to this study (written form) * With a current treatment by aripiprazole already scheduled * With Tics compatible with TEP/fMRI exams * Having (for women only) effective contraception throughout participation in the study. Exclusion Criteria \* : * Male or Female * A serious not controlled psychiatric comorbidity * A serious, evolving or debilitating pathology with a potential influence on the study * Drug-taking with serotonergic effects (e.g., amphetamine, cocaine, MDMA, SSRIs, mianserin) * Contraindication for fMRI and PET (e.g., pacemaker, ferromagnetic implant, claustrophobia) * Women breastfeeding * Protected or restricted person (administratively or in judicial terms) * Participants to another study with radiations or radiotracers since less of one year, participants to a concomitant study * Do not speak french
Where this trial is running
Bron and 1 other locations
- Service de neurologie C Hôpital neurologique Pierre Wertheimer/GHE Hospices Civils de Lyon — Bron, France (Recruiting)
- Centre de Référence Syndrome Gilles de la Tourette Département de Neurologie Pôle des Maladies du Système Nerveux Hôpital de la Pitié-Salpêtrière — Paris, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Benjamin PASQUEREAU
- Email: benjamin.pasquereau@isc.cnrs.fr
- Phone: +33 437 911 241
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.