Comparing Problem Solving Treatment combined with duloxetine with Problem Solving Treatment alone for patients with major depressive disorder in primary care

INTERVENTION: Trade Name: Cymbalta Product Name: duloxetine Product Code: Cymbalta Pharmaceutical Form: Capsule, hard CONDITION: Major depressive disorder (episode or recurrent), moderately severe as principal DSM‐IV diagnosis. ; MedDRA version: 9.1 Level: LLT Classification code 10012378 Term: Depression PRIMARY OUTCOME: Main Objective: The primary objective is assessing the depressive symptom reduction rate of mono‐treatment (PST) compared to combined treatment (PST and duloxetine) in patients with major depressive disorder. In other words, testing the hypothesis that combined treatment is more effective than mono‐treatment in patients with major depressive disorder. Primary end point(s): 50% reduction at IDS‐SR30 score from baseline to study periods’ endpoint Secondary Objective: 1. are there intervening variables such as somatic symptoms that interact with the treatment condition? ; 2. temporal relationship between the reduction of depressive symptoms and somatic symptoms. ; 3. does providing a structured way of assisting patients with their difficulties by PST will enhance adherence to pharmacotherapy (see protocol) ; 4. does PST will enhance of the sense of mastery and coping in MDD patients ?; 5. do other characteristics, such as demographic variables, depression characteristics (severity and duration) and co morbidity predict a different outcome for either treatment condition. ; 6. what are the effects of the interventions on symptom reduction rates and the quality of life 12 months after the beginning of the treatment.; ; ; INCLUSION CRITERIA: PHQ‐9 > 9 (first screening) actual screening Principal DSM‐IV diagnosis: major depressive disorder (episode or recurrent), moderately severe. IDS‐SR30 score > 22 Age 18‐65 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