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

NCT ID: NCT01733199

Last Updated: 2018-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 225 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2017-03-31

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.

Conditions

Parkinson's Disease; Secondary Behavioural Addiction

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

BA-

Patient with no secondary behavioural addiction

Group Type: EXPERIMENTAL

questionnaires

Intervention Type: OTHER

Summons of patients and filling questionnaire.

BA+/DDS-

Patients with secondary behavioural addiction, without dopamine dysregulation syndrome

Group Type: EXPERIMENTAL

questionnaires

Intervention Type: OTHER

Summons of patients and filling questionnaire.

BA+/DDS+

Patients with secondary behavioural addiction and dopamine dysregulation syndrome

Group Type: EXPERIMENTAL

questionnaires

Intervention Type: OTHER

Summons of patients and filling questionnaire.

Interventions

questionnaires

Summons of patients and filling questionnaire.

Intervention Type: OTHER

Eligibility Criteria

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

• The same as the main study
• To have a treatment by pramipexole in the immediate release form

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) :

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marie GRALL-BRONNEC

Role: PRINCIPAL_INVESTIGATOR

Nantes UH

Locations

Nantes University Hospital

Nantes, , France

Countries

France

Other Identifiers

RC12_0059

Identifier Type: -

Identifier Source: org_study_id