RecruitingRare disease

Study on Impulsivity Control in Adults with Tourette Syndrome Using [18F]-Altanserin and Aripiprazole

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the involvement of the serotonergic system in controlling impulsivity in individuals with Tourette disorder. The study will use two treatments: [18F]-Altanserin, which is administered as an injection, and Aripiprazole, which is taken orally. The purpose of the study is to explore the relationship between the availability of certain brain receptors and changes in impulsivity in adults with Tourette disorder.

Participants in the study will receive the treatments as part of their routine care. The study will involve monitoring changes in brain activity and impulsivity levels over time. This will help researchers understand how the treatments might affect impulsivity in people with Tourette disorder. The study will not involve any new or experimental treatments, as both [18F]-Altanserin and Aripiprazole are already used in medical practice.

The study will take place over a period of time, during which participants will undergo various assessments to measure changes in their condition. These assessments will include brain imaging techniques to observe how the brain responds to the treatments. The findings from this study could provide valuable insights into the management of impulsivity in Tourette disorder, potentially leading to improved treatment strategies in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the diagnosis of Tourette disorder according to the DSM-5 criteria and ensuring the participant is between 18-65 years old.
Participants must provide written informed consent and confirm their current treatment with aripiprazole is already scheduled.
Step 2
Baseline evaluation
A baseline evaluation is performed to measure initial levels of impulsivity and other relevant clinical scores. This involves completing specific questionnaires and tasks designed to assess impulsivity.
The availability of serotonergic 5-HT2A receptors is measured using imaging techniques such as TEP/fMRI exams.
Step 3
Medication administration
Participants continue their routine treatment with aripiprazole, administered orally as per their existing schedule. The dosage and frequency are determined by the participant's healthcare provider.
In addition, [18F]-altanserin is administered via injection for imaging purposes to measure receptor availability.
Step 4
Ongoing assessments
Throughout the study, regular assessments are conducted to monitor changes in impulsivity and other clinical scores. These assessments involve repeating the initial questionnaires and tasks.
Imaging exams are repeated to track changes in the binding potential of [18F]-altanserin and the BOLD signal in the brain.
Step 5
Final evaluation
At the end of the study period, a final evaluation is conducted to determine the correlation between changes in receptor availability and impulsivity scores.
The study aims to establish links between serotonergic system activity and impulsivity control in individuals with Tourette disorder.

Who can join the trial?

8 criteria

Must be either male or female.
Must have a diagnosis of Tourette Disorder according to the DSM-5, which is a guide used by doctors to diagnose mental health conditions.
Must be between the ages of 18 and 65.
Must be a member of a social security scheme in France.
Must provide written consent to participate in the study, meaning you agree to join the study after understanding what it involves.
Must already have a current treatment with aripiprazole planned. Aripiprazole is a medication used to treat certain mental health conditions.
Must have tics that are suitable for TEP/fMRI exams. Tics are sudden, repetitive movements or sounds, and TEP/fMRI are types of brain imaging tests.
For women, must use effective contraception during the study to prevent pregnancy.

Who cannot join the trial?

5 criteria

Individuals who do not have a diagnosis of Tourette disorder cannot participate. Tourette disorder is a condition that causes people to make involuntary sounds and movements called tics.
Participants must be within the specified age range, which is not provided here, but typically means there are age limits for who can join.
Both males and females are eligible, so gender is not a reason for exclusion.
People who are considered part of a vulnerable population, which usually means those who might be at higher risk of harm or exploitation, are not automatically excluded.
There are no specific principal exclusion criteria listed, meaning there are no additional specific reasons provided that would prevent someone from participating.

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Hospices Civils De Lyon
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Lyon, France

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Investigated drugs

ARITEP: This is a medication being studied for its effects on impulsivity in adults with Tourette's syndrome. The trial aims to understand how this medication interacts with the serotonergic system, specifically the 5-HT2A receptors, which are believed to play a role in controlling impulsive behavior. The study is focused on observing changes in impulsivity when patients begin treatment with this medication as part of their regular care.

What is already known about the treatment

Aripiprazole – Aripiprazole is typically administered orally in the form of tablets or liquid. It is currently used in medicine to treat various mental health conditions, including Tourette disorder, and is well-documented in medical literature. The main therapeutic indication for Aripiprazole in this context is to manage symptoms of Tourette disorder, particularly impulsivity. At the molecular level, Aripiprazole works by modulating the activity of dopamine and serotonin receptors in the brain, particularly the 5-HT2A receptor, which is believed to play a role in controlling impulsivity. It is classified pharmacologically as an atypical antipsychotic.

Investigated diseases

Tourette Disorder – Tourette Disorder is a neurological condition characterized by repetitive, involuntary movements and vocalizations called tics. These tics can vary in frequency and intensity, often changing over time. The disorder typically begins in childhood, with symptoms usually appearing between the ages of 5 and 10. Motor tics might include blinking, shrugging, or head jerking, while vocal tics can involve grunting, throat clearing, or repeating words. The severity of tics can fluctuate, sometimes worsening with stress or excitement. Although the exact cause is unknown, it is believed to involve a combination of genetic and environmental factors.