Clinical trial NCT03970239: Serotonin in Impulse Control Disorders in Parkinson's Disease
Official title: Role of the Serotoninergic System in Impulse Control Disorders in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Impulse Control Disorders
Keywords: Parkinson's disease
Impulse control disorders
Serotoninergic system
Positron Emission Tomography (PET)
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-05-31
Enrollment: 45
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Impulse control disorders are frequent and troublesome in patients with Parkinson's disease. However, the cerebral functional alterations related to impulse control disorders in Parkinson's disease are poorly understood and may involve the serotoninergic system besides alterations in the dopaminergic system.

The primary objective of this study is to investigate the cerebral functional alterations in the serotoninergic system in patients with Parkinson's disease and impulse control disorders using Positron Emission Tomography with highly specific radiotracers of serotonin transporter (SERT) using \[11 Carbon\]-3-amino-4-(2-dimethylaminomethylphenylsulfanyl)-benzonitrile (\[11C\]-DASB) and of serotonin 5-Hydroxytryptamine 2A (5-HT2A) receptor using \[18 Fluorine\]-altanserin (\[18F\]-altanserin), in comparison to patients with Parkinson's disease without impulse control disorders and healthy volunteers.


Eligibility criteria: Inclusion Criteria:

Group 1 Patients with Parkinson's disease and impulse control disorders

* Patients with a diagnosis of clinically established or clinically probable Parkinson's disease according to the Movement Disorder Society (MDS) Clinical Diagnostic Criteria for Parkinson's Disease
* Patients aged ≥ 30 and ≤ 80 years old
* Patients presenting currently with impulse control disorders or having presented with impulse control disorders in the last 2 years (Ardouin Behavior Scale score ≥2 for one or more of the following items: eating behavior; compulsive buying; pathological gambling; hypersexuality) , following the diagnosis of Parkinson's disease
* Patients able to sign the consent document and willing to participate in all aspects of the study

Patients with Parkinson's disease and without impulse control disorders

* Patients with a diagnosis of clinically established or clinically probable Parkinson's disease according to the MDS Clinical Diagnostic Criteria for Parkinson's Disease
* Patients aged ≥ 30 and ≤ 80 years old
* Patients not currently presenting with impulse control disorders and other hyperdopaminergic behaviors and not having ever presented with impulse control disorders
* Patients able to sign a consent document and willing to participate in all aspects of the study

Group 2 : Healthy volunteers

Subjects aged ≥ 30 and ≤ 80 years old

* Subjects not currently presenting with impulse control disorders or hyperdopaminergic behaviors and not having ever presented with impulse control disorders
* Subjects able to sign a consent document and willing to participate in all aspects of the study

Exclusion Criteria:

Group 1 :

Patients with Parkinson's disease and impulse control disorders

* Patients with Montreal Cognitive Assessment score ≤24 or Frontal Assessment Battery score ≤14
* Patients not able to perform Positron Emission Tomography (PET) or Magnetic Resonance Imaging (MRI)
* Patients presenting with other severe medical condition or other parkinsonian syndrome
* Patients treated with Deep Brain Stimulation or levodopa pump
* Patients treated with drugs or consuming recreative drugs specifically interfering with the serotoninergic, noradrenergic or opiate systems in the last 3 months
* Patients presenting with substance dependence, except for tobacco
* Patients with Body Mass Index ≥ 35kilogram/meters2 (kg/m2)

Patients with Parkinson's disease and without impulse control disorders

* Patients with Montreal Cognitive Assessment score ≤24 or Frontal Assessment Battery score ≤14
* Patients not able to perform Positron Emission Tomography or Magnetic Resonance Imaging
* Patients presenting with other severe medical condition or other parkinsonian syndrome
* Patients treated with Deep Brain Stimulationor levodopa pump
* Patients treated with drugs or consuming recreative drugs specifically interfering with the serotoninergic, noradrenergic or opiate systems in the last 3 months
* Patients presenting with substance dependence, except for tobacco
* Patients with Body Mass Index ≥35kg/m2

Group 2 : Healthy volunteers

* Subjects with Montreal Cognitive Assessment score ≤24 or Frontal Assessment Battery score ≤14
* Subjects not able to perform Positron Emission Tomography or Magnetic Resonance Imaging
* Subjects presenting with neurologic, psychiatric or other severe medical condition
* Subjects treated with drugs or consuming recreative drugs specifically interfering with the serotoninergic, noradrenergic or opiate systems in the last 3 months
* Subjects presenting with substance dependence, except for tobacco
* Subjects with Body Mass Index ≥35kg/m2

Primary outcomes:
measure: Difference in binding potential of [18 Fluorine]-altanserin ([18F]-altanserin) and [11 Carbon]-3-amino-4-(2-dimethylaminomethylphenylsulfanyl)-benzonitrile ([11C]-DASB) ([11C]-DASB)
timeFrame: 2-3 days
Secondary outcomes:
measure: Ardouin Scale of Behavior in Parkinson's Disease (ASBPD)
timeFrame: 2-3 days
measure: Questionnaire For Impulsive-Compulsive Disorders In Parkinson's Disease-Rating Scale (QUIP-RS)
timeFrame: 2-3 days
measure: Urgency, Premeditation (lack of), Perseverance (lack of), Sensation Seeking Impulsive Behavior Scale (UPPS Impulsive Behavior Scale)
timeFrame: 2-3 days
measure: Movement Disorder Society (MDS) Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
timeFrame: 2-3 days
measure: Beck Depression Inventory II (BDI-II)
timeFrame: 2-3 days
measure: Starkstein Apathy Scale (SAS)
timeFrame: 2-3 days
measure: State-Trait Anxiety Inventory -Y (STAI-Y)
timeFrame: 2-3 days
measure: Snaith-Hamilton Pleasure Scale (SHAPS)
timeFrame: 2-3 days
measure: Temporal Experience of Pleasure Scale (TEPS)
timeFrame: 2-3 days
measure: Stop Signal Reaction Time (SSRT)
timeFrame: 2-3 days
measure: Discounting rate
timeFrame: 2-3 days
measure: Proportion of premature responses
timeFrame: 2-3 days
measure: Polymorphism rs6313 (or T102C) of the serotonin 5-Hydroxytryptamine 2A (5-HT2A) receptor
timeFrame: 2-3 days
measure: Polymorphism 5-HydroxyTryptamine (serotonin) Transporter Gene-Linked Polymorphic Region (5-HTTLPR)/rs25531 of the serotonin transporter (SERT)
timeFrame: 2-3 days
measure: Magnetic Resonance Imaging metrics: anatomical imaging
timeFrame: 2-3 days
measure: Magnetic Resonance Imaging metrics: Diffusion Weighted imaging
timeFrame: 2-3 days
measure: Magnetic Resonance Imaging metrics: Resting State Functional Imaging
timeFrame: 2-3 days
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon
name: Stéphane THOBOIS, PhD
role: PRINCIPAL_INVESTIGATOR
References: