RANDOMIZED DOUBLE-BLIND STUDY TO EVALUATE THE ADJUVANT EFFECT OF POLYNSATURED FATTY ACIDS OMEGA-3 IN THERAPY WITH S.S.R.I. PAROXETINE MESYLATE IN UNIPOLAR MOOD DEPRESSION AND RECURRENT DEPRESSION

INTERVENTION: Product Name: fish oil 30 EPA/DHA Pharmaceutical Form: Capsule, hard Concentration unit: g gram(s) Concentration type: equal Concentration number: 1‐ Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Trade Name: DAPAROX Pharmaceutical Form: Film‐coated tablet Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20‐ CONDITION: Mood depression ; MedDRA version: 9.1 Level: LLT Classification code 10012374 Term: Depressed mood PRIMARY OUTCOME: Main Objective: To evaluate the adjuvant effect of polyunsatured fatty acids omega‐3 on mood of depressed patients during therapy with paroxetine mesylate, a Selective Serotonin Reuptake Inhibitor. Primary end point(s): to obtain an improvement in Hamilton Rating Scale for Depression HAM‐D and Clinical Global Impression CGI score. Measure of efficacy will be a change in HAM‐D total scores from baseline to endpoint. We hypothesize that SSRI PUFAs will be more efficacious than SSRI alone for the treatment of major depression. Secondary Objective: INCLUSION CRITERIA: patients aged between 18 and 65, male or female, affected by major depressive disorder or recurrent depressive disorder according to DSM‐IV‐TR and the Hamilton Depression Rating Scale HAM‐D 16 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