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NCT Number: NCT05942716

Serotonin Control of Impulsivity in Tourette Disorder

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.

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Key information

Conditions

Tourette Disorder Basal Ganglia Diseases Behavior Brain Diseases Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Impulsive Behavior Mental Disorders Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurodevelopmental Disorders Tic Disorders Tourette Syndrome

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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, participants to a concomitant study
  • Do not speak french

Treatment and study plan

Administration of a PET radiotracer

Drug

A highly selective 5-HT2A receptor ligand ([18F]-altanserin) will be injected to patients before each PET scan. The IV injection in the arm (via a catheter) will be performed in continue during a period of 2 hours in the imaging centre (CERMEP) before the acquisition. The dose will be 2,6 MBq/kg +/- 10 % depending the prescription of the nuclear medicine.

Patients will be evaluated twice, one time free of neuroleptic treatment and a second time during stable chronic treatment by neuroleptic.

Primary outcomes

  1. 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

  1. Correlation coefficients between receptor-specific imaging data (PET) and other clinical/behavioral scores.

    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 other clinical scores and task performance of TD patients.

  2. Correlation coefficients between functional imaging data (fMRI) 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 BOLD signal measured voxel-by-voxel in the whole brain and the evolution of scores BIS11 in TD patients.

  3. Correlation coefficients between functional imaging data (fMRI) and other clinical/behavioral scores.

    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 BOLD signal measured voxel-by-voxel in the whole brain and the evolution of other clinical scores and task performance of TD patients.

Study contacts

Contact information is provided by the study sponsor or research team.

Benjamin PASQUEREAU

CONTACT

[email protected]

+33 437 911 241

Stephane THOBOIS

CONTACT

[email protected]

+33 472 357 222

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: ARITEP

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Jul 12, 2023
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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