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Clinical Trials/NCT05942716
NCT05942716
Recruiting
Phase 2

Involvement of the Serotonergic System in the Control of Impulsivity in Tourette Disorder.

Hospices Civils de Lyon2 sites in 1 country25 target enrollmentSeptember 24, 2024

Overview

Phase
Phase 2
Intervention
Administration of a PET radiotracer
Conditions
Tourette Disorder
Sponsor
Hospices Civils de Lyon
Enrollment
25
Locations
2
Primary Endpoint
Correlation coefficients between receptor-specific imaging data (PET) and scores of impulsivity measured by the Barratt scale (BIS11).
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 24, 2024
End Date
September 24, 2028
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Tourette disorder

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.

Intervention: Administration of a PET radiotracer

Outcomes

Primary Outcomes

Correlation coefficients between receptor-specific imaging data (PET) and scores of impulsivity measured by the Barratt scale (BIS11).

Time Frame: 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 Outcomes

  • 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 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 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.)

Study Sites (2)

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