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NCT Number: NCT01733199

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).

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Behavior Brain Diseases Central Nervous System Diseases Disruptive, Impulse Control, and Conduct Disorders Gambling Mental Disorders Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Risk-Taking Secondary Behavioural Addiction Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Nantes University Hospital

Nantes, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

questionnaires

Other

Summons of patients and filling questionnaire.

Primary outcomes

  1. 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.

  2. 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.

  3. 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)

  4. Genetic axis : distribution of allele frequencies and genotypic

    Distribution of allele frequencies and genotypic

Secondary outcomes

  1. Treatments except the anti-parkinsonism ones

    Psychopathological axis

  2. drug misuse

    Psychopathological axis

  3. addiction and punding antecedents

    Psychopathological axis

  4. ADHD antecedents

    Psychopathological axis

  5. impulsivity profile

    Psychopathological axis

  6. Age of onset of the Parkinson's disease

    Neurological axis

  7. stage and form of the Parkinson's disease

    Neurological axis included dyskinesia and involuntary abnormal movements

  8. time course of Parkinson's disease

    Neurological axis

  9. family history of Parkinson's disease

    Neurological axis

  10. anti-parkinsonism treatments

    Neurological axis

  11. 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.

  12. 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.

  13. 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.

  14. 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.

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: PARKADD

Important dates

Study start
2012
Primary completion
2016
Study completion
2017
First posted
Nov 26, 2012
Registry last updated
Feb 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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