Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
ID05942716

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

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

25

Participants Needed

2

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Tourette disorder (TD) is a neurodevelopmental condition marked by motor and vocal tics, often linked with psychiatric issues involving impulsivity such as obsessive-compulsive disorder, attention-deficit hyperactivity disorder, and intermittent explosive disorder. Researchers seek to better understand the role of the brain's serotonin (5-HT) system, especially the 5-HT2A receptor, in controlling both cognitive and emotional symptoms in TD. Since aripiprazole, a drug commonly used in TD, blocks these receptors, the study aims to explore this receptor's involvement in impulsive behaviors in TD patients. The study involves 25 adult patients with TD who are already scheduled to receive treatment with aripiprazole (5-15 mg). Each participant will undergo two evaluations: one without neuroleptic medication and one during stable treatment. During these sessions, patients will receive an intravenous injection of a specialized PET radiotracer ([18F]-altanserin) that maps 5-HT2A receptor binding in the brain, combined with functional MRI scans to assess brain activity. Participants will be monitored through advanced brain imaging techniques, including PET and fMRI, to collect data on receptor binding and brain function. Researchers will then analyze how these imaging results correlate with impulsivity scores measured by the Barratt Impulsiveness Scale (BIS11) and other clinical assessments. The main outcome will be evaluated in the year following the imaging sessions as part of a detailed data analysis process. The study is sponsored by Hospices Civils de Lyon and will run until September 2028.

CONDITIONS

Brief 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 according to DSM-5
  • Aged between 18 and 65 years
  • Member of a social security scheme in France
  • Provided written informed consent to participate
  • Scheduled for current treatment with aripiprazole
  • Tics compatible with PET/fMRI examinations
  • Women must use effective contraception throughout the study
Not Eligible

You will not qualify if you...

  • Serious uncontrolled psychiatric comorbidity
  • Serious, evolving, or debilitating illness that may affect the study
  • Use of drugs with serotonergic effects (e.g., amphetamine, cocaine, MDMA, SSRIs, mianserin)
  • Contraindications for fMRI or PET (e.g., pacemaker, ferromagnetic implants, claustrophobia)
  • Women who are breastfeeding
  • Legally protected or restricted persons
  • Participation in another study with radiation or radiotracers within the past year
  • Not speaking French

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Duration of treatment evaluations depends on scheduling of two PET scans

Participants receive two PET scans with injection of a serotonin receptor radiotracer, once without neuroleptic treatment and once during stable chronic neuroleptic treatment to assess impulsivity control.

2 visits (in-person) for PET scans

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

Loading map...

Research Team

B

Benjamin PASQUEREAU

S

Stephane THOBOIS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Similar Trials

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here