Serotonin Control of Impulsivity in Tourette Disorder

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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.

Первичные конечные точки

• Correlation coefficients between receptor-specific imaging data (PET) and scores of impulsivity measured by the Barratt scale (BIS11). [Срок оценки: As the analysis requires a complex imaging processing, this outcome measure will be assessed in the year following the acquisition.]

Вторичные конечные точки (3)

• Correlation coefficients between receptor-specific imaging data (PET) and other clinical/behavioral scores. [Срок оценки: As the analysis requires a complex imaging processing, this outcome measure will be assessed in the year following the acquisition.]
• Correlation coefficients between functional imaging data (fMRI) and scores of impulsivity measured by the Barratt scale (BIS11). [Срок оценки: As the analysis requires a complex imaging processing, this outcome measure will be assessed in the year following the acquisition.]
• Correlation coefficients between functional imaging data (fMRI) and other clinical/behavioral scores. [Срок оценки: As the analysis requires a complex imaging processing, this outcome measure will be assessed in the year following the acquisition.]

Критерии участия

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 2 центра

• Service de neurologie C Hôpital neurologique Pierre Wertheimer/GHE Hospices Civils de Lyon — Bron
• Centre de Référence Syndrome Gilles de la Tourette Département de Neurologie Pôle des Mala — Paris

Идентификаторы

NCT: NCT05942716 · 69HCL22_0683

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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