Behavioural Addiction and Genetics in Parkinson's Disease

NCT02319395 | Completed

• 1 other identifier: P100133
• Study Type: observational
• Target: 332
• Locations: 1 country
• Sites: 1

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).

Conditions

Parkinson Disease; Impulse Control Disorders

Keywords

Parkinson's Disease; Behaviour addiction; Dopamine agonist; Genetic.

Outcome Measures

Primary Outcomes (1)

• Allele frequency of 50 genetic markers (polymorphisms) will be compared between cases and controls.

  baseline

Secondary Outcomes (5)

• number of patients with a diagnostic of ICD according to the MINI

  baseline

• Total UPDRS (Unified Parkinson's Disease Rating Scale) score

  baseline

• Total score of the MMSE (Mini Mental State Examination)

  baseline

• Sub scores at the temperament and Character Inventory (revised version, TCI-R)

  baseline

• Number of subject in each group with personal or familial history of addiction

  baseline

Study Arms (2)

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

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

Interventions

Blood Sampling and DNA collection GENETIC

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.

cases; controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

PD patients

You may qualify if:

• Case Group
• Age upper or equal to 30 years
• Caucasian European (2 parents and 4 grandparents born in Europe)
• Parkinson's disease according to the criteria of UKPDSBB
• 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
• 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.
• Affiliation to a social security
• Signature of the consent form
• Control Group
• Age upper or equal to 30 years
• Caucasian European (2 parents and 4 grandparents born in Europe)
• Parkinson's disease according to the criteria of UKPDSBB
• Time evolution of the disease than or equal to 5 years

You may not qualify if:

• Case Group
• No Parkinson's disease or atypical parkinsonian syndrome
• Taking neuroleptic except clozapine for patients with AC
• Behavioral Addiction having started BEFORE taking the antiparkinsonian treatment
• Control Group
• No Parkinson's disease or atypical parkinsonian syndrome
• Taking neuroleptic included clozapine for control patients
• Behavioral Addiction having started BEFORE taking the antiparkinsonian treatment
• Patient with guardianship, deprived of his liberty by judicial decision

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Groupe Hospitalier La Pitié Salpêtrière

Paris, 75013, France

Location

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.

MeSH Terms

Conditions

Parkinson Disease; Disruptive, Impulse Control, and Conduct Disorders

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• jean-christophe Corvol, MD, PhD

  Assitance-Publique Hopitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2014
• First Posted: December 18, 2014
• Study Start: November 1, 2011
• Primary Completion: November 1, 2015
• Study Completion: March 1, 2016
• Last Updated: January 25, 2017

Record last verified: 2016-03

Locations

FR (1)