Academic trial of sertraline in depression

INTERVENTION: Study Group: Sertraline, 50 mg daily (1 capsule) for 4 weeks by oral route. At the end of this period incremental doses of 50 mg every two weeks can be made, if HAM‐D is not improved over 25% regarding the day of inclusion of the patient and until the maximum dose (200 mg is reached), unless that: ‐ In the fourth week assessment or subsequent assessments the patient shows worsening of their symptoms ‐ if in The sixth week the patient maintains stable symptoms over the time of inclusion. In both cases, study treatment will be discontinued and the patient will receive standard treatment at the discretion of the specialist. Control group: Placebo (identical presentation), in the same therapeutic regimen, maintaining similar considerations of the study group. Both groups will receive interventions of support on a weekly basis if required. The treatment will have a total duration of 10 weeks in both groups. After completing the 10 weeks of trial treatment, patients with clinical improvement continue treatment with a maintenance dose as the patient's progress, to complete a period of 6 months. Clinical improvement is considered for those cases that at the end of the study are classified into one of the following categories: remission, improvement or partial improvement above 25% reduction in HAM‐D according to the day of inclusion. CONDITION: major depressive disorder PRIMARY OUTCOME: Changes in the score on the Hamilton Rating Scale for Depression (HAM‐D). Measurement time: Pre‐enrollment and on days 0, 7, 14, 21, 28, 42, 56, 70 and 6 months SECONDARY OUTCOME: Changes in the score on the Clinical Global Impression scale (CGI). Measurement time: Days 0, 7, 14, 21, 28, 42, 56, 70 and 6 months Change in the score on the Sexual Dysfunction Scale of the Massachusetts General Hospital Days 0, 42, 70 and 6 months Weight (Kgs). Measurement time: Pre‐enrollment and on days 0, 7, 14, 21, 28, 42, 56, 70 and 6 months Adverse Event (AE). Measurement time: Days 7, 14, 21, 28, 42, 56, 70 and 6 months ‐Type of EA (name of the AE) ‐Intensity of AE (mild, moderate, severe) ‐Severity of AE (Serious or not) ‐Duration of the AE (to be recorded over time) ‐Attitude to drugs (to be recorded if there were changes, dose modification, interruption or discontinuance of treatment) ���Result of the AE (1 Cured, 2 Enhanced, 3 persistent,4 Sequelae) ‐Causal Relationship of the AE (definite, likely, probable, possible, unrelated, unknown) ‐Treatment indicated (treatment received by each patient for the AE occurred) INCLUSION CRITERIA: Pre‐inclusion criteria Patients with major depressive disorder, diagnosed by DSM‐IV. Patients with a value in the Hamilton Rating Scale for Depression (HAM‐D) between 19 and 36 points inclusive. Patients of both sexes between 18 and 65, inclusive. Patients with capacity to consent for give their written consent to participate. 5. HCG (chorionic gonadotropin hormone) negative (for women of childbearing age). Inclusion criteria Patients whose score on the HAM‐D at the end of the week pre‐inclusion: o Do not change or, o Decrease less than 25% without being less than 19 points or, o It increases without exceeding 36 points. On the basis of physical examination, medical history, ECG, and the results of the tests: ‐ Chemical Hematology: hemoglobin, hematocrit, total leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils and platelet count, creatinine, glucose, albumin, total bilirubin, alkaline phosphatase, SGPT and SGOT and cituria conducted in the pre‐