Clinical Trial: Behavioural Addiction and Genetics in Parkinson's Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Behavioural Addiction and Genetics in Parkinson's Disease

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).

Detailed Summary:

Objective: To identify susceptibility genes to impulse control disorders in Parkinson's Disease.

Study design: Genetic association study.

Primary objective:

To identify the susceptibility genes in behavior addiction in Parkinson's Disease

Secondary endpoints:

  • To compare the clinical, neurological and psychiatric features of parkinsonian patients with behavior addiction compared to the control population. In case of differences between these groups, interaction will be studied with genetic factors
  • Identify a psychometric profile from the TCI-R scale corresponding to the "hyperdopaminergic" subjects with AC personality

Patient selection:

Cases: patients with Parkinson's disease (PD) and impulse control disorder (ICD) as defined by a score greater than or equal to 2 or 3 scores greater than or equal to 2 at the "Evaluation Comportementale de la Maladie de Parkinson" scale (ECMP, Ardouin et al. 2009) for hyperdopaminergic items.

Controls: PD patients without impulse control disorder (ICD) as defined by a score of 0 or 1 at each hyperdopaminergic items AND no more than 2 items with a score of 1. Controls must have been treated with at least 300 mg of Levodopa equivalent daily dose for more than 12 months. Controls will be matched for sex, age, and age at onset of PD.

Number of subjects: 200 cases and 200 controls.

Clinical assessment: motor sc
Sponsor: Assistance Publique - Hôpitaux de Paris

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: September 29, 2014
Date Started: November 2011
Date Completion:
Last Updated: January 24, 2017
Last Verified: March 2016