Clinical trial NCT05942716: Serotonin Control of Impulsivity in Tourette Disorder
Official title: Involvement of the Serotonergic System in the Control of Impulsivity in Tourette Disorder.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Tourette Disorder
Keywords: Tourette
Serotonin
Impulsivity
Neuroimaging
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-07-12
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: * 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

Primary outcomes:
measure: Correlation coefficients between receptor-specific imaging data (PET) and scores of impulsivity measured by the Barratt scale (BIS11).
timeFrame: As the analysis requires a complex imaging processing, this outcome measure will be assessed in the year following the acquisition.
Secondary outcomes:
measure: Correlation coefficients between receptor-specific imaging data (PET) and other clinical/behavioral scores.
timeFrame: As the analysis requires a complex imaging processing, this outcome measure will be assessed in the year following the acquisition.
measure: Correlation coefficients between functional imaging data (fMRI) and scores of impulsivity measured by the Barratt scale (BIS11).
timeFrame: As the analysis requires a complex imaging processing, this outcome measure will be assessed in the year following the acquisition.
measure: Correlation coefficients between functional imaging data (fMRI) and other clinical/behavioral scores.
timeFrame: As the analysis requires a complex imaging processing, this outcome measure will be assessed in the year following the acquisition.
Other outcomes:
Locations:
city: Bron
country: France
facility: Service de neurologie C Hôpital neurologique Pierre Wertheimer/GHE Hospices Civils de Lyon
city: Paris
country: France
facility: Centre de Référence Syndrome Gilles de la Tourette Département de Neurologie Pôle des Maladies du Système Nerveux Hôpital de la Pitié-Salpêtrière
Study officials:
References: