Behavioural Addictions Occurring During a Dopaminergic Treatment Prescribe Under Parkinson's Disease: Study of the Psychopathological, Neurological, Pharmacokinetic and Genetic Profiles (PARKADD)
Primary Purpose
Parkinson's Disease, Secondary Behavioural Addiction
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
questionnaires
Sponsored by
About this trial
This is an interventional diagnostic trial for Parkinson's Disease focused on measuring Parkinson's disease, Behavioural addictions, Pathological gambling, Dopamine agonist, Dopamine dysregulation syndrome, Pharmacokinetic, Pramipexole
Eligibility Criteria
Main study
Inclusion criteria:
- To be 18 years old or more (both genders)
- To have idiopathic Parkinson's disease, without important cognitive troubles, treated by usually prescribed drugs
- To have a treatment established since 6 months at least
Exclusion criteria:
- To be under tutelage (a French protecting measure for persons with altered judgement)
- To have a secondary Parkinson's disease
- To have received a chirurgical treatment for Parkinson's disease
- To present obvious cognitive disturbances
Ancillary study (pharmacokinetic axis) :
Inclusion criteria:
- The same as the main study
- To have a treatment by pramipexole in the immediate release form
Exclusion criteria:
- The same as the main study
- Association of the pramipexole with others molecules
- To use to have a behavioural addiction resolved by a diminution of the dosage before the study
Sites / Locations
- Nantes University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
BA-
BA+/DDS-
BA+/DDS+
Arm Description
Patient with no secondary behavioural addiction
Patients with secondary behavioural addiction, without dopamine dysregulation syndrome
Patients with secondary behavioural addiction and dopamine dysregulation syndrome
Outcomes
Primary Outcome Measures
Psychopathological axis : score of sensation seeking (S Score) of the impulsivity questionnaire "UPPS"
This choice is founded on the fact that patients suffering of DDS are described as being impulsive, misusing their anti-parkinsonism treatment in the purpose of stimulate themselves, suggesting they have a high level of sensation and novelty seeking.
Pharmacological axis : Area under the curve of the pramipexole concentration
Area under the curve of the pramipexole concentration in function of the time between 2 intakes of pramipexole.
Neurological axis : Unified Parkinson's Disease Rating Scale (UPDRS) III score
UPDRS III score, with axial under-score in ON and OFF DOPA (Parkinson's disease severity)
Genetic axis : distribution of allele frequencies and genotypic
Distribution of allele frequencies and genotypic
Secondary Outcome Measures
Treatments except the anti-parkinsonism ones
Psychopathological axis
drug misuse
Psychopathological axis
addiction and punding antecedents
Psychopathological axis
ADHD antecedents
Psychopathological axis
impulsivity profile
Psychopathological axis
Age of onset of the Parkinson's disease
Neurological axis
stage and form of the Parkinson's disease
Neurological axis included dyskinesia and involuntary abnormal movements
time course of Parkinson's disease
Neurological axis
family history of Parkinson's disease
Neurological axis
anti-parkinsonism treatments
Neurological axis
Residual plasmatic concentration of the pramipexole
Pharmacological axis The data of the pharmacological axis are measured after analyzes of the blood samples collected in that evaluation, only for the 80 patients participated to the ancillary study.
median pharmacokinetic parameters of pramipexole
Pharmacological axis The data of the pharmacological axis are measured after analyzes of the blood samples collected in that evaluation, only for the 80 patients participated to the ancillary study.
study of the hepatic and renal functions
Pharmacological axis The data of the pharmacological axis are measured after analyzes of the blood samples collected in that evaluation, only for the 80 patients participated to the ancillary study.
Physiopathological covariates
Pharmacological axis age, gender, weight, creatinine and prothrombin rates The data of the pharmacological axis are measured after analyzes of the blood samples collected in that evaluation, only for the 80 patients participated to the ancillary study.
Full Information
NCT ID
NCT01733199
First Posted
November 20, 2012
Last Updated
February 14, 2018
Sponsor
Nantes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01733199
Brief Title
Behavioural Addictions Occurring During a Dopaminergic Treatment Prescribe Under Parkinson's Disease: Study of the Psychopathological, Neurological, Pharmacokinetic and Genetic Profiles
Acronym
PARKADD
Official Title
Behavioural Addictions Occurring During a Dopaminergic Treatment Prescribe Under Parkinson's Disease: Study of the Psychopathological, Neurological, Pharmacokinetic and Genetic Profiles.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital
4. Oversight
5. Study Description
Brief Summary
This study is composed of a main study and an ancillary one. The objective of the main study is to define, on the psychopathological, neurological, pharmacokinetic and genetic plan, the predictive factors for developing a behavioural addiction (BA) secondarily to the dopaminergic treatment, associated or not to a dopamine dysregulation syndrome (DDS), in patients with Parkinson's disease.
3 particular profiles of patients will be established:
BA- : no secondary behavioural addiction
BA+/DDS-: secondary behavioural addiction, without dopamine dysregulation syndrome
BA+/DDS+: secondary behavioural addiction, with dopamine dysregulation syndrome
We wish in particular:
To differentiate, among the BA+ subjects, those for who is a DDS from those for who we can evoke a side effect of the dopaminergic treatment
To demonstrate that the BA+/DDS- subjects present pharmacokinetic particularities causing the occurrence of the BA.
To clarify the possible relationship between the dosage and the pharmacodynamics of the treatment (especially that of pramipexole) in one hand, and the developing of BA in the other hand.
Demonstrate that the subjects BA + / DDS- are individually genetic vulnerability (related to the dopamine system), originally from the occurrence of the BA.
This study has several levels of evaluation, we chose describe the methodology of the study in 3 axis : Psychopathology axis, Neurological axis and pharmacokinetic axis.
The pharmacokinetic aspects will be studied only on a part of the sample, in an ancillary study centered on the pharmacokinetic of the pramipexole (in its immediate release form).
Detailed Description
This is a monocentric study with a recruitment period comprised between October 2012 and April 2016. The recruitment occurs during the consultations in the service of neurology. If the subjects are eligible, the study is proposed to them, and an evaluation is fixed in the next days. This evaluation consists in an individual face-to-face interview based on standardized and semi-structured questionnaires, during approximately one and a half hour. It's focused on the different characteristics of Parkinson's disease, and on psychiatric and addictive co morbidities. The evaluation is completed by a set of self-administered questionnaires focused on impulsivity and Attention Deficit Hyperactivity Disorder (ADHD).
For the 80 patients participated to the ancillary study only, a blood sample will be realized when the patient will arrived, just before the intake of his treatment (to obtain the residual plasmatic concentration). A second sample will be realized at a different time for each patient, to cover the entirety of the kinetic between 2 intakes of pramipexole (immediate release form) via the entire sample. The second blood sample will be realized four hours after the first one at the most. After this second sample, the patient will have completed his participation to the study.
Secondly, monitoring including a self-questionnaire booklet and a saliva sample will be offered to all patients who completed the initial visit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Secondary Behavioural Addiction
Keywords
Parkinson's disease, Behavioural addictions, Pathological gambling, Dopamine agonist, Dopamine dysregulation syndrome, Pharmacokinetic, Pramipexole
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
225 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BA-
Arm Type
Experimental
Arm Description
Patient with no secondary behavioural addiction
Arm Title
BA+/DDS-
Arm Type
Experimental
Arm Description
Patients with secondary behavioural addiction, without dopamine dysregulation syndrome
Arm Title
BA+/DDS+
Arm Type
Experimental
Arm Description
Patients with secondary behavioural addiction and dopamine dysregulation syndrome
Intervention Type
Other
Intervention Name(s)
questionnaires
Intervention Description
Summons of patients and filling questionnaire.
Primary Outcome Measure Information:
Title
Psychopathological axis : score of sensation seeking (S Score) of the impulsivity questionnaire "UPPS"
Description
This choice is founded on the fact that patients suffering of DDS are described as being impulsive, misusing their anti-parkinsonism treatment in the purpose of stimulate themselves, suggesting they have a high level of sensation and novelty seeking.
Title
Pharmacological axis : Area under the curve of the pramipexole concentration
Description
Area under the curve of the pramipexole concentration in function of the time between 2 intakes of pramipexole.
Title
Neurological axis : Unified Parkinson's Disease Rating Scale (UPDRS) III score
Description
UPDRS III score, with axial under-score in ON and OFF DOPA (Parkinson's disease severity)
Title
Genetic axis : distribution of allele frequencies and genotypic
Description
Distribution of allele frequencies and genotypic
Secondary Outcome Measure Information:
Title
Treatments except the anti-parkinsonism ones
Description
Psychopathological axis
Title
drug misuse
Description
Psychopathological axis
Title
addiction and punding antecedents
Description
Psychopathological axis
Title
ADHD antecedents
Description
Psychopathological axis
Title
impulsivity profile
Description
Psychopathological axis
Title
Age of onset of the Parkinson's disease
Description
Neurological axis
Title
stage and form of the Parkinson's disease
Description
Neurological axis included dyskinesia and involuntary abnormal movements
Title
time course of Parkinson's disease
Description
Neurological axis
Title
family history of Parkinson's disease
Description
Neurological axis
Title
anti-parkinsonism treatments
Description
Neurological axis
Title
Residual plasmatic concentration of the pramipexole
Description
Pharmacological axis The data of the pharmacological axis are measured after analyzes of the blood samples collected in that evaluation, only for the 80 patients participated to the ancillary study.
Title
median pharmacokinetic parameters of pramipexole
Description
Pharmacological axis The data of the pharmacological axis are measured after analyzes of the blood samples collected in that evaluation, only for the 80 patients participated to the ancillary study.
Title
study of the hepatic and renal functions
Description
Pharmacological axis The data of the pharmacological axis are measured after analyzes of the blood samples collected in that evaluation, only for the 80 patients participated to the ancillary study.
Title
Physiopathological covariates
Description
Pharmacological axis age, gender, weight, creatinine and prothrombin rates The data of the pharmacological axis are measured after analyzes of the blood samples collected in that evaluation, only for the 80 patients participated to the ancillary study.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main study
Inclusion criteria:
To be 18 years old or more (both genders)
To have idiopathic Parkinson's disease, without important cognitive troubles, treated by usually prescribed drugs
To have a treatment established since 6 months at least
Exclusion criteria:
To be under tutelage (a French protecting measure for persons with altered judgement)
To have a secondary Parkinson's disease
To have received a chirurgical treatment for Parkinson's disease
To present obvious cognitive disturbances
Ancillary study (pharmacokinetic axis) :
Inclusion criteria:
The same as the main study
To have a treatment by pramipexole in the immediate release form
Exclusion criteria:
The same as the main study
Association of the pramipexole with others molecules
To use to have a behavioural addiction resolved by a diminution of the dosage before the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie GRALL-BRONNEC
Organizational Affiliation
Nantes UH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nantes University Hospital
City
Nantes
Country
France
12. IPD Sharing Statement
Learn more about this trial
Behavioural Addictions Occurring During a Dopaminergic Treatment Prescribe Under Parkinson's Disease: Study of the Psychopathological, Neurological, Pharmacokinetic and Genetic Profiles
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