NCT05942716 Serotonin Control of Impulsivity in Tourette Disorder
| NCT ID | NCT05942716 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Hospices Civils de Lyon |
| Condition | Tourette Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2024-09-24 |
| Primary Completion | 2027-09-24 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 25 participants in total. It began in 2024-09-24 with a primary completion date of 2027-09-24.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Tourette disorder (TD) is a neurodevelopmental disorder characterized by motor and vocal tics. It is often associated with multiple psychiatric comorbidities involving a high degree of impulsivity such as obsessive-compulsive disorders (OCD), attention-deficit hyperactivity disorders (ADHD), and intermittent explosive disorders (IED). Although a substantial body of clinical studies have emphasized the role of the dopamine system in motor symptoms, little is known about how the serotonergic (5-HT) system modulate both cognitive and affective abilities in TD. Several lines of evidence suggest that different 5-HT receptor subtypes may constitute a crucial factor in the development and maintenance of different symptoms. Because abnormal 5-HT2A receptor bindings have been reported in patients with TD and aripiprazole (drug of first choice) is a 5-HT2A antagonist, we hypothesize that 5-HT2A receptors may play an important role in regulating psychiatric symptoms in TD such as those characterized by impulsive behaviors. To investigate the involvement of 5-HT2A receptors in TD, we propose to perform a multimodal imaging study with 20 adult patients (ON and OFF treatment). Neuroimaging data will be collected with a hybrid system that simultaneously combines the positron emission tomography (PET) and the functional magnetic resonance imaging (fMRI). A highly selective PET radiotracer (\[18F\]-altanserin) will map 5-HT2A receptor bindings in the whole brain, while fMRI will provide detail information regarding the altered brain activities.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05942716 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Tourette Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05942716 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05942716 currently recruiting?
Yes, NCT05942716 is actively recruiting participants. Contact the research team at benjamin.pasquereau@isc.cnrs.fr for enrollment information.
Where is the NCT05942716 trial being conducted?
This trial is being conducted at Bron, France, Paris, France.
Who is sponsoring the NCT05942716 clinical trial?
NCT05942716 is sponsored by Hospices Civils de Lyon. The trial plans to enroll 25 participants.