Clinical trial NCT01733199: Behavioural Addictions Occurring During a Dopaminergic Treatment Prescribe Under Parkinson's Disease: Study of the Psychopathological, Neurological, Pharmacokinetic and Genetic Profiles
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parkinson's Disease
Secondary Behavioural Addiction
Keywords: Parkinson's disease
Behavioural addictions
Pathological gambling
Dopamine agonist
Dopamine dysregulation syndrome
Pharmacokinetic
Pramipexole
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2012-11-26
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Psychopathological axis : score of sensation seeking (S Score) of the impulsivity questionnaire "UPPS"
measure: Pharmacological axis : Area under the curve of the pramipexole concentration
measure: Neurological axis : Unified Parkinson's Disease Rating Scale (UPDRS) III score
measure: Genetic axis : distribution of allele frequencies and genotypic
Secondary outcomes:
measure: Treatments except the anti-parkinsonism ones
measure: drug misuse
measure: addiction and punding antecedents
measure: ADHD antecedents
measure: impulsivity profile
measure: Age of onset of the Parkinson's disease
measure: stage and form of the Parkinson's disease
measure: time course of Parkinson's disease
measure: family history of Parkinson's disease
measure: anti-parkinsonism treatments
measure: Residual plasmatic concentration of the pramipexole
measure: median pharmacokinetic parameters of pramipexole
measure: study of the hepatic and renal functions
measure: Physiopathological covariates
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: Nantes UH
name: Marie GRALL-BRONNEC
role: PRINCIPAL_INVESTIGATOR
References: