EVALUATE THE TOLERABILITY AND EFFICACY OF OMEGA 3 ON MOOD ANDMOTOR SYMPTOMS OF PATIENTS SUFFERING FROM PARKINSON DISEASE - ND

• Conditions: MOOD DEPRESSION; MedDRA version: 6.1Level: PTClassification code 10012374

• Registration Number: EUCTR2006-003717-41-IT
• Lead Sponsor: POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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