Behavioural Addictions Occurring During a Dopaminergic Treatment Prescribe Under Parkinson's Disease: Study of the Psychopathological, Neurological, Pharmacokinetic and Genetic Profiles (PARKADD)

Nantes University Hospital (NUH)

Status and phase: Completed; Phase 4

Conditions: Parkinson's Disease; Secondary Behavioural Addiction

Treatments: Other: questionnaires

Study type: Interventional

Funder types: Other

Identifiers

NCT01733199

RC12_0059

Details and patient eligibility

About

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).

Full 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.

Enrollment: 225 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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225 participants in 3 patient groups

BA-

Experimental group

Description:

Patient with no secondary behavioural addiction

Treatment:

Other: questionnaires

BA+/DDS-

Experimental group

Description:

Patients with secondary behavioural addiction, without dopamine dysregulation syndrome

Treatment:

Other: questionnaires

BA+/DDS+

Experimental group

Description:

Patients with secondary behavioural addiction and dopamine dysregulation syndrome

Treatment:

Other: questionnaires