Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
NCT05942716

Serotonin Control of Impulsivity in Tourette Disorder

Led by Hospices Civils de Lyon · Updated on 2024-12-04

25

Participants Needed

2

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Serotonin Control of Impulsivity in Tourette Disorder

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or Female
  • Diagnosed with Tourette Disorder following the DSM-5
  • Age between 18 and 65 years
  • Member of a social security scheme in France
  • Provided freely-given written informed consent
  • Currently scheduled for treatment with aripiprazole
  • Have tics compatible with PET/fMRI exams
  • For women only: using effective contraception throughout the study
Not Eligible

You will not qualify if you...

  • Presence of serious uncontrolled psychiatric comorbidity
  • Serious, evolving, or debilitating medical condition that could affect the study
  • Use of drugs with serotonergic effects (e.g., amphetamine, cocaine, MDMA, SSRIs, mianserin)
  • Contraindications to PET or fMRI (e.g., pacemaker, ferromagnetic implant, claustrophobia)
  • Women who are breastfeeding
  • Legally protected or restricted individuals
  • Participation in another study involving radiation or radiotracers within the past year or concurrent study participation
  • Inability to speak French

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Service de neurologie C Hôpital neurologique Pierre Wertheimer/GHE Hospices Civils de Lyon

Bron, France, 69677

Actively Recruiting

2

Centre de Référence Syndrome Gilles de la Tourette Département de Neurologie Pôle des Maladies du Système Nerveux Hôpital de la Pitié-Salpêtrière

Paris, France, 75013

Not Yet Recruiting

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Research Team

B

Benjamin PASQUEREAU

CONTACT

S

Stephane THOBOIS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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