Behavioural Addictions Occurring During a Dopaminergic Treatment Prescribe Under Parkinson's Disease: Study of the Psychopathological, Neurological, Pharmacokinetic and Genetic Profiles (PARKADD)
Behavioural Addictions Occurring During a Dopaminergic Treatment Prescribe Under Parkinson's Disease: Study of the Psychopathological, Neurological, Pharmacokinetic and Genetic Profiles.
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).
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- Phase 4
Contacts et emplacements
Lieux d'étude
-
-
-
Nantes, France
- Nantes University Hospital
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: BA-
Patient with no secondary behavioural addiction
|
Summons of patients and filling questionnaire.
|
|
Expérimental: BA+/DDS-
Patients with secondary behavioural addiction, without dopamine dysregulation syndrome
|
Summons of patients and filling questionnaire.
|
|
Expérimental: BA+/DDS+
Patients with secondary behavioural addiction and dopamine dysregulation syndrome
|
Summons of patients and filling questionnaire.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
|---|---|
|
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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
|---|---|
|
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.
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Marie GRALL-BRONNEC, Nantes UH
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- RC12_0059
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .