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Recruiting Phase 2 NCT05942716

Serotonin Control of Impulsivity in Tourette Disorder

Trial Parameters

Condition Tourette Disorder
Sponsor Hospices Civils de Lyon
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 25
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2024-09-24
Completion 2027-09-24
Interventions
Administration of a PET radiotracer

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, participa

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