Serotonin Control of Impulsivity in Tourette Disorder

Phase 2

Recruiting

• Conditions: Tourette Disorder
• Interventions: Drug: Administration of a PET radiotracer

• Registration Number: NCT05942716
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-04
• Study First Submitted QC: 2023-07-04
• Study First Posted: 2023-07-12
• Study Start: 2024-09-24
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-04
• Primary Completion: 2027-09-24
• Study Completion: 2028-09-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tourette disorder	Administration of a PET radiotracer	25 mixt adult patients with TD. Patients will be recruited if a current treatment by aripiprazole (5-15 mg) is already scheduled before the study.

Primary Outcome Measures

Name	Time	Method
Correlation coefficients between receptor-specific imaging data (PET) and scores of impulsivity measured by the Barratt scale (BIS11).	As the analysis requires a complex imaging processing, this outcome measure will be assessed in the year following the acquisition.	Correlation coefficients between changes in the binding potential (BPND) of \[18F\]-altanserin measured voxel-by-voxel in the whole brain and the evolution of scores BIS11 in TD patients.

Secondary Outcome Measures

Name	Time	Method
Correlation coefficients between functional imaging data (fMRI) and scores of impulsivity measured by the Barratt scale (BIS11).	As the analysis requires a complex imaging processing, this outcome measure will be assessed in the year following the acquisition.	Correlation coefficients between changes in the BOLD signal measured voxel-by-voxel in the whole brain and the evolution of scores BIS11 in TD patients.
Correlation coefficients between receptor-specific imaging data (PET) and other clinical/behavioral scores.	As the analysis requires a complex imaging processing, this outcome measure will be assessed in the year following the acquisition.	Correlation coefficients between changes in the binding potential (BPND) of \[18F\]-altanserin measured voxel-by-voxel in the whole brain and the evolution of other clinical scores and task performance of TD patients.
Correlation coefficients between functional imaging data (fMRI) and other clinical/behavioral scores.	As the analysis requires a complex imaging processing, this outcome measure will be assessed in the year following the acquisition.	Correlation coefficients between changes in the BOLD signal measured voxel-by-voxel in the whole brain and the evolution of other clinical scores and task performance of TD patients.

Trial Locations

Locations (2)

Service de neurologie C Hôpital neurologique Pierre Wertheimer/GHE Hospices Civils de Lyon; 🇫🇷 Bron, France

Centre de Référence Syndrome Gilles de la Tourette Département de Neurologie Pôle des Maladies du Système Nerveux Hôpital de la Pitié-Salpêtrière; 🇫🇷 Paris, France