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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT03970239
Date of registration:	06/05/2019
Prospective Registration:	Yes
Primary sponsor:	Hospices Civils de Lyon
Public title:	Serotonin in Impulse Control Disorders in Parkinson's Disease Park-IMPULSE
Scientific title:	Role of the Serotoninergic System in Impulse Control Disorders in Parkinson's Disease
Date of first enrolment:	May 13, 2019
Target sample size:	45
Recruitment status:	Recruiting
URL:	https://clinicaltrials.gov/show/NCT03970239
Study type:	Interventional
Study design:	Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
Phase:	N/A

Countries of recruitment
France

Contacts

Name:	THOBOIS STEPHANE
Address:
Telephone:
Email:
Affiliation:

Name:	Stéphane THOBOIS, PhD
Address:
Telephone:
Email:
Affiliation:	Hospices Civils de Lyon

Name:	Stéphane THOBOIS, PhD
Address:
Telephone:	4 72 35 72 18
Email:	stephane.thobois@chu-lyon.fr
Affiliation:

Key inclusion & exclusion 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

Age minimum: 30 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Impulse Control Disorders

Parkinson Disease

Intervention(s)

Drug: Positron Emission Tomography using [18 Fluorine]-altanserin ([18F]-altanserin)

Drug: Positron Emission Tomography using [11 Carbon]-3-amino-4-(2-dimethylaminomethylphenylsulfanyl)-benzonitrile ([11C]-DASB) and [18 Fluorine]-altanserin ([18F]-altanserin)

Primary Outcome(s)

Difference in binding potential of [18 Fluorine]-altanserin ([18F]-altanserin) and [11 Carbon]-3-amino-4-(2-dimethylaminomethylphenylsulfanyl)-benzonitrile ([11C]-DASB) ([11C]-DASB) [Time Frame: 2-3 days]

Secondary Outcome(s)

Magnetic Resonance Imaging metrics: anatomical imaging [Time Frame: 2-3 days]

Proportion of premature responses [Time Frame: 2-3 days]

Movement Disorder Society (MDS) Unified Parkinson's Disease Rating Scale (MDS-UPDRS) [Time Frame: 2-3 days]

Questionnaire For Impulsive-Compulsive Disorders In Parkinson's Disease-Rating Scale (QUIP-RS) [Time Frame: 2-3 days]

Starkstein Apathy Scale (SAS) [Time Frame: 2-3 days]

Temporal Experience of Pleasure Scale (TEPS) [Time Frame: 2-3 days]

Magnetic Resonance Imaging metrics: Resting State Functional Imaging [Time Frame: 2-3 days]

Discounting rate [Time Frame: 2-3 days]

Magnetic Resonance Imaging metrics: Diffusion Weighted imaging [Time Frame: 2-3 days]

Ardouin Scale of Behavior in Parkinson's Disease (ASBPD) [Time Frame: 2-3 days]

Polymorphism 5-HydroxyTryptamine (serotonin) Transporter Gene-Linked Polymorphic Region (5-HTTLPR)/rs25531 of the serotonin transporter (SERT) [Time Frame: 2-3 days]

Polymorphism rs6313 (or T102C) of the serotonin 5-Hydroxytryptamine 2A (5-HT2A) receptor [Time Frame: 2-3 days]

Snaith-Hamilton Pleasure Scale (SHAPS) [Time Frame: 2-3 days]

Beck Depression Inventory II (BDI-II) [Time Frame: 2-3 days]

Urgency, Premeditation (lack of), Perseverance (lack of), Sensation Seeking Impulsive Behavior Scale (UPPS Impulsive Behavior Scale) [Time Frame: 2-3 days]

State-Trait Anxiety Inventory -Y (STAI-Y) [Time Frame: 2-3 days]

Stop Signal Reaction Time (SSRT) [Time Frame: 2-3 days]

Secondary ID(s)

2019-000340-99

69HCL18_0012

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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