Behavioural Addictions Occurring During a Dopaminergic Treatment Prescribe Under Parkinson's Disease: Study of the Psychopathological, Neurological and Pharmacokinetic Profiles
Information source: Nantes University Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Parkinson's Disease; Secondary Behavioural Addiction
Intervention: questionnaires (Other)
Phase: Phase 4
Status: Recruiting
Sponsored by: Nantes University Hospital Official(s) and/or principal investigator(s): Marie GRALL-BRONNEC, Principal Investigator, Affiliation: Nantes UH
Overall contact: Juliette LEBOUCHER, Phone: 02 40 84 76 25, Email: juliette.leboucher@chu-nantes.fr
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 and pharmacokinetic 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.
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).
Clinical Details
Official title: Behavioural Addictions Occurring During a Dopaminergic Treatment Prescribe Under Parkinson's Disease: Study of the Psychopathological, Neurological and Pharmacokinetic Profiles.
Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Primary outcome: Psychopathological axis : score of sensation seeking (S Score) of the impulsivity questionnaire "UPPS"Pharmacological axis : Area under the curve of the pramipexole concentration Neurological axis : Unified Parkinson's Disease Rating Scale (UPDRS) III score
Secondary outcome: Treatments except the anti-parkinsonism onesdrug misuse addiction and punding antecedents ADHD antecedents impulsivity profile Age of onset of the Parkinson's disease stage and form of the Parkinson's disease time course of Parkinson's disease family history of Parkinson's disease anti-parkinsonism treatments Residual plasmatic concentration of the pramipexole median pharmacokinetic parameters of pramipexole study of the hepatic and renal functions Physiopathological covariates
Detailed description:
This is a monocentric study with a recruitment period comprised between October 2012 and
October 2015. 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.
An extraction of DNA and a conservation of the sample during ten years are planned, for the
possible realisation of a pharmacogenetic analysis, if the results of the pharmacokinetic
analysis imply an interest of such a study.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Juliette LEBOUCHER, Phone: 02 40 84 76 25, Email: juliette.leboucher@chu-nantes.fr
Nantes University Hospital, Nantes, France; Recruiting Juliette LEBOUCHER, Phone: 02 40 84 76 25, Email: juliette.leboucher@chu-nantes.fr Marie GRALL-BRONNEC, Principal Investigator Pascal DERKINDEREN, Sub-Investigator Eric DAILLY, Sub-Investigator Tiphaine ROUAUD, Sub-Investigator
Additional Information
Starting date: October 2012
Last updated: March 24, 2015
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