Mood depression MedDRA version: 9.1 Level: LLT Classification code 10012374 Term: Depressed mood
Conditions
Interventions
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, ha
Sponsors
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: - liver insufficiency - kidney insufficiency - important coagulation failure - anticoagulant therapy - pregnancy - concomitant treatment with other drugs, than allowed ones - positive history for other pharmacological treatment during last month before recruitment - presence of psychotic disorders Benzodiazepine by need until maximum dosage of lorazepam 2,5 mg /d or equivalent dosage of diazepam 12,5 mg/d
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;Secondary Objective: ;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. | — |
Countries
Italy
Outcome results
None listed