Tourette DisorderPhase 2ARITEPNCT05942716
Serotonin Control of Impulsivity in Tourette Disorder
A Phase 2 study testing Administration of a PET radiotracer in people with Tourette Disorder, run by Hospices Civils de Lyon at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tourette Disorder
- What is being tested?
- Administration of a PET radiotracer
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesFrance
- Study dates
- 24 Sep 2024to 24 Sep 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Service de neurologie C Hôpital neurologique Pierre Wertheimer/GHE Hospices Civils de Lyon
Bron, 69677
Stephane THOBOIS, MD
- Not yet recruiting
Centre de Référence Syndrome Gilles de la Tourette Département de Neurologie Pôle des Maladies du Système Nerveux Hôpital de la Pitié-Salpêtrière
Paris, 75013
Yulia WORBE, MD, +33 142 161 316, yworbe@gmail.com
About this study
Official title: Involvement of the Serotonergic System in the 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.
- Conditions
- Tourette Disorder
- Being tested
- Administration of a PET radiotracer
- Keywords
- Tourette, Serotonin, Impulsivity, Neuroimaging
- Medical subject headings
- Tourette Syndrome, Impulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of a PET radiotracerDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Tourette disorder | Experimental | 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. Receives: Drug: Administration of a PET radiotracer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation coefficients between receptor-specific imaging data (PET) and scores of impulsivity measured by the Barratt scale (BIS11).
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.
Measured: As the analysis requires a complex imaging processing, this outcome measure will be assessed in the year following the acquisition.
Secondary outcomes (3)
Correlation coefficients between receptor-specific imaging data (PET) and other clinical/behavioral scores.
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.
Measured: 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).
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.
Measured: 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.
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.
Measured: As the analysis requires a complex imaging processing, this outcome measure will be assessed in the year following the acquisition.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start24 Sep 2024
- Primary completion24 Sep 2027 (estimated)
- Study completion24 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tourette DisorderStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05942716
- Sponsor's protocol ID
- 69HCL22_0683
- Acronym
- ARITEP
- Status last verified
- Dec 2024
- First submitted
- 4 Jul 2023
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Involvement of the Serotonergic System in the Control of Impulsivity in Tourette Disorder.
- ClinicalTrials.gov ID
- NCT05942716
- Acronym / sponsor ID
- ARITEP / 69HCL22_0683
- Conditions
- Tourette Disorder
- Keywords
- Tourette, Serotonin, Impulsivity, Neuroimaging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 24 Sep 2024 (actual)
- Primary completion
- 24 Sep 2027 (estimated)
- Study completion
- 24 Sep 2028 (estimated)
- First posted
- 12 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tourette disorder | Experimental | Drug: Administration of a PET radiotracer25 mixt adult patients with TD. Patients will be recruited if a current treatment by aripiprazole (5-15 mg) is already scheduled before the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Administration of a PET radiotracerA 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. | Drug | Tourette disorder |
Primary outcome
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.
3 secondary outcomes
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 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 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Tourette Disorder
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Deep Brain Stimulation Therapy in Movement Disorders
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Exploring the Role of Neuroactive Steroids in Tourette Syndrome
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Administration of a PET radiotracer in people with Tourette Disorder, run by Hospices Civils de Lyon at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin PASQUEREAU (+33 437 911 241, benjamin.pasquereau@isc.cnrs.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.