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

NCT01733199 | Completed Phase 4

• 1 other identifier: RC12_0059
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

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).

Conditions

Parkinson's Disease; Secondary Behavioural Addiction

Keywords

Parkinson's disease; Behavioural addictions; Pathological gambling; Dopamine agonist; Dopamine dysregulation syndrome; Pharmacokinetic; Pramipexole

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (14)

• Treatments except the anti-parkinsonism ones

• drug misuse

• addiction and punding antecedents

• ADHD antecedents

• impulsivity profile

Study Arms (3)

BA-

EXPERIMENTAL

Patient with no secondary behavioural addiction

Other: questionnaires

BA+/DDS-

EXPERIMENTAL

Patients with secondary behavioural addiction, without dopamine dysregulation syndrome

Other: questionnaires

BA+/DDS+

EXPERIMENTAL

Patients with secondary behavioural addiction and dopamine dysregulation syndrome

Other: questionnaires

Interventions

questionnaires OTHER

Summons of patients and filling questionnaire.

BA+/DDS+; BA+/DDS-; BA-

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• To have a treatment by pramipexole in the immediate release form
• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes University Hospital

Nantes, France

Location

MeSH Terms

Conditions

Parkinson Disease; Gambling

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Risk-Taking; Behavior; Disruptive, Impulse Control, and Conduct Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Marie GRALL-BRONNEC

  Nantes UH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2012
• First Posted: November 26, 2012
• Study Start: October 1, 2012
• Primary Completion: May 1, 2016
• Study Completion: March 1, 2017
• Last Updated: February 15, 2018

Record last verified: 2018-02

Locations

FR (1)