MOOD DEPRESSION MedDRA version: 6.1 Level: PT Classification code 10012374
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Adult patients attending the clinical centre for Parkinson disease of Neuroscience Department of A. Gemelli Hospital, Catholic University of Sacred Heart, in Rome with: - diagnosis of Parkinson disease - antiparkinson therapy steady since at least 6 months Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: monogenic type of Parkinson disease (diagnosis genetically confirmed) - liver insufficiency - kidney insufficiency - important coagulation failure and anticoagulant therapy - valproate therapy - presence of psychiatric disorders (psychotic disorders) severely interfering with the evaluation - pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the tolerability and efficacy of polyunsatured fatty acids omega-3 consumption on mood (depression and anhedonia) and motor symptoms of patients suffering from Parkinson disease with steady therapy since 6 months.;Secondary Objective: ND;Primary end point(s): ND | — |
Countries
Italy