We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Behavioural Addiction and Genetics in Parkinson's Disease (BADGE-PD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02319395
Recruitment Status : Completed
First Posted : December 18, 2014
Last Update Posted : January 25, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
The " Behavioural Addiction and Genetics in Parkinson's Disease " study (BADGE-PD) is a national (France), multicenter, genetic association, case-control study to identify genetic factors associated with behavioural addiction (or Impulse Control Disorders, ICD) related to dopamine agonists treatment in Parkinson's disease (PD). Polymorphisms of candidate genes supposed to be involved in this adverse effect will be compared in 200 PD patients with ICD (n=200) and 200 matched PD patients without ICD (n=200).

Condition or disease Intervention/treatment
Parkinson Disease Impulse Control Disorders Genetic: Blood Sampling and DNA collection

Show Show detailed description

Layout table for study information
Study Type : Observational
Actual Enrollment : 332 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Behavioural Addiction and Genetics in Parkinson's Disease
Study Start Date : November 2011
Actual Primary Completion Date : November 2015
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
cases
Presence of ICD in PD patients (cases) is defined as a score ≥ 2 at 1 hyperdopaminegic item, or 2 scores ≥ 2 at 1 hyperdopaminergic item of the scale for assessment of behavior and mood in PD (ECMP).
Genetic: Blood Sampling and DNA collection
One blood sampling during the study. A small number (1 to 5) of markers type "tag SNPs" or "coding SNP" " (single nucleotide polymorphism, SNP) will be selected for each of the selected genes, for a total of 50 markers (representing 20 to 25 genes). Non-silent coding SNP, that may have a functional effect, will be included as a priority. Genotyping is carried out by the method of genotyping VeraCode Goldengate.

controls
Absence of ICD in PD patients (controls) is defined as a score ≤ 1 at all hyperdopaminergic items of ECMP and no more than 2 items of a score = 1.
Genetic: Blood Sampling and DNA collection
One blood sampling during the study. A small number (1 to 5) of markers type "tag SNPs" or "coding SNP" " (single nucleotide polymorphism, SNP) will be selected for each of the selected genes, for a total of 50 markers (representing 20 to 25 genes). Non-silent coding SNP, that may have a functional effect, will be included as a priority. Genotyping is carried out by the method of genotyping VeraCode Goldengate.




Primary Outcome Measures :
  1. Allele frequency of 50 genetic markers (polymorphisms) will be compared between cases and controls. [ Time Frame: baseline ]

Secondary Outcome Measures :
  1. number of patients with a diagnostic of ICD according to the MINI [ Time Frame: baseline ]
  2. Total UPDRS (Unified Parkinson's Disease Rating Scale) score [ Time Frame: baseline ]
  3. Total score of the MMSE (Mini Mental State Examination) [ Time Frame: baseline ]
  4. Sub scores at the temperament and Character Inventory (revised version, TCI-R) [ Time Frame: baseline ]
  5. Number of subject in each group with personal or familial history of addiction [ Time Frame: baseline ]

Biospecimen Retention:   Samples With DNA
One blood sampling during the study. A small number (1 to 5) of markers type "tag SNPs" or "coding SNP" will be selected for each of the selected genes, for a total of 50 markers (representing 20 to 25 genes). Non-silent coding SNP, that may have a functional effect, will be included as a priority. Genotyping is carried out by the method of genotyping VeraCode Goldengate.


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
PD patients
Criteria

Inclusion criteria :

Case Group

  1. Age upper or equal to 30 years
  2. Caucasian European (2 parents and 4 grandparents born in Europe)
  3. Parkinson's disease according to the criteria of UKPDSBB
  4. With a behavioral addiction defined as:

    • A score greater than or equal to 2 or 3 scores greater than or equal to 2 at hyperdopaminergic following items of Ardouin's scale (ECMP): eating behaviors, creativity, hobbyism, risk-taking behaviors, compulsive shopping, pathological gambling, hypersexuality, cyber-addiction, and Punding.
    • Onset under dopamine agonist or under L-DOPA
    • Present at the inclusion visit
    • OR in the past (<6 years). For these patients, the scale of Ardouin must have been passed at the time of behavior trouble or within 3 months after its disappearance.
  5. Affiliation to a social security
  6. Signature of the consent form

Control Group

  1. Age upper or equal to 30 years
  2. Caucasian European (2 parents and 4 grandparents born in Europe)
  3. Parkinson's disease according to the criteria of UKPDSBB
  4. Time evolution of the disease than or equal to 5 years
  5. Having taken during its evolution a dopamine agonist dose at least equivalent to 300 mg of L-DOPA for at least 12 months.
  6. Not having behavioral addiction

    • Not current, defined as a score of 0 or 1 and at most two items with a score of 1 on all items above and addiction to L-DOPA.
    • Neither passed, given authenticated by the semi-structured interview retrospective finding a score of 0 or 1 on all items hyperdopaminergic of Ardouin's scale (see above) AND no more than two items with a score of 1 and addiction to L-DOPA.
  7. Affiliation to a social security
  8. Signature of the consent form

Exclusion criteria :

Case Group

  1. No Parkinson's disease or atypical parkinsonian syndrome
  2. Taking neuroleptic except clozapine for patients with AC
  3. Behavioral Addiction having started BEFORE taking the antiparkinsonian treatment

Control Group

  1. No Parkinson's disease or atypical parkinsonian syndrome
  2. Taking neuroleptic included clozapine for control patients
  3. Behavioral Addiction having started BEFORE taking the antiparkinsonian treatment
  4. Patient with guardianship, deprived of his liberty by judicial decision

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02319395


Locations
Layout table for location information
France
Groupe Hospitalier La Pitié Salpêtrière
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Layout table for investigator information
Principal Investigator: jean-christophe Corvol, MD, PhD Assitance-Publique Hopitaux de Paris
Layout table for additonal information
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02319395    
Other Study ID Numbers: P100133
First Posted: December 18, 2014    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: March 2016
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Parkinson's Disease
Behaviour addiction
Dopamine agonist
Genetic.
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Behavior, Addictive
Disruptive, Impulse Control, and Conduct Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Compulsive Behavior
Impulsive Behavior
Mental Disorders