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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01733199
First received: November 20, 2012
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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).


Condition Intervention Phase
Parkinson's Disease
Secondary Behavioural Addiction
Other: questionnaires
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Behavioural Addictions Occurring During a Dopaminergic Treatment Prescribe Under Parkinson's Disease: Study of the Psychopathological, Neurological and Pharmacokinetic Profiles.

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Psychopathological axis : score of sensation seeking (S Score) of the impulsivity questionnaire "UPPS" [ Designated as safety issue: No ]
    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 [ Designated as safety issue: No ]
    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 [ Designated as safety issue: No ]
    UPDRS III score, with axial under-score in ON and OFF DOPA (Parkinson's disease severity)


Secondary Outcome Measures:
  • Treatments except the anti-parkinsonism ones [ Designated as safety issue: No ]
    Psychopathological axis

  • drug misuse [ Designated as safety issue: No ]
    Psychopathological axis

  • addiction and punding antecedents [ Designated as safety issue: No ]
    Psychopathological axis

  • ADHD antecedents [ Designated as safety issue: No ]
    Psychopathological axis

  • impulsivity profile [ Designated as safety issue: No ]
    Psychopathological axis

  • Age of onset of the Parkinson's disease [ Designated as safety issue: No ]
    Neurological axis

  • stage and form of the Parkinson's disease [ Designated as safety issue: No ]
    Neurological axis included dyskinesia and involuntary abnormal movements

  • time course of Parkinson's disease [ Designated as safety issue: No ]
    Neurological axis

  • family history of Parkinson's disease [ Designated as safety issue: No ]
    Neurological axis

  • anti-parkinsonism treatments [ Designated as safety issue: No ]
    Neurological axis

  • Residual plasmatic concentration of the pramipexole [ Designated as safety issue: No ]
    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.

  • median pharmacokinetic parameters of pramipexole [ Designated as safety issue: No ]
    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.

  • study of the hepatic and renal functions [ Designated as safety issue: No ]
    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.

  • Physiopathological covariates [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 250
Study Start Date: October 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BA-
Patient with no secondary behavioural addiction
Other: questionnaires
Summons of patients and filling questionnaire.
Experimental: BA+/DDS-
Patients with secondary behavioural addiction, without dopamine dysregulation syndrome
Other: questionnaires
Summons of patients and filling questionnaire.
Experimental: BA+/DDS+
Patients with secondary behavioural addiction and dopamine dysregulation syndrome
Other: questionnaires
Summons of patients and filling questionnaire.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01733199

Contacts
Contact: Juliette LEBOUCHER 02 40 84 76 25 juliette.leboucher@chu-nantes.fr

Locations
France
Nantes University Hospital Recruiting
Nantes, France
Contact: Juliette LEBOUCHER    02 40 84 76 25    juliette.leboucher@chu-nantes.fr   
Principal Investigator: Marie GRALL-BRONNEC         
Sub-Investigator: Pascal DERKINDEREN         
Sub-Investigator: Eric DAILLY         
Sub-Investigator: Tiphaine ROUAUD         
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Marie GRALL-BRONNEC Nantes UH
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01733199     History of Changes
Other Study ID Numbers: RC12_0059
Study First Received: November 20, 2012
Last Updated: January 7, 2014
Health Authority: France : Agence National de Sécurité du Médicament et des produits de santé

Keywords provided by Nantes University Hospital:
Parkinson's disease
Behavioural addictions
Pathological gambling
Dopamine agonist
Dopamine dysregulation syndrome
Pharmacokinetic
Pramipexole

Additional relevant MeSH terms:
Parkinson Disease
Behavior, Addictive
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Compulsive Behavior
Impulsive Behavior
Dopamine
Dopamine Agents
Dopamine Agonists
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on July 22, 2014