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Serotonin Control of Impulsivity in Tourette Disorder

NCT ID: NCT05942716

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-24

Study Completion Date

2028-09-24

Brief Summary

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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

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Conditions

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Tourette Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Administration of a PET radiotracer

Intervention Type 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.

Interventions

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Administration of a PET radiotracer

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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Bron, , France

Site Status RECRUITING

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

Paris, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Benjamin PASQUEREAU

Role: CONTACT

[email protected]
+33 437 911 241

Stephane THOBOIS

Role: CONTACT

[email protected]
+33 472 357 222

Facility Contacts

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Stephane THOBOIS, MD

Role: primary

Yulia WORBE, MD

Role: primary

[email protected]
+33 142 161 316

Other Identifiers

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69HCL22_0683

Identifier Type: -

Identifier Source: org_study_id