DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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 ones

drug 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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017