major depressive disorder
Conditions
Interventions
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% regardin
Sponsors
Dalhousie university, Halifax, Nova Scotia, Canada
National Coordinating Center of Clinical Trials (CENCEC)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
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: • Do not change or, • Decrease less than 25% without being less than 19 points or, • 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-inclusion visit, the patient is, in the opinion of the investigator and according to normal laboratory healthy enough to enter the study.
Exclusion criteria
Exclusion criteria: Psychiatric treatment of patients with minimal therapeutic dose in the two months prior to inclusion (depot neuroleptics, antidepressants, lithium, or carbamazepine valproates). Presence of other psychiatric disorder diagnosed or referred that explain the Depression: Bipolar Disorder, Schizophrenia or Mental Retardation. Patients at risk of suicide or attempted suicide in the last year or with scores between 3 and 4 in the suicide item of HAM-D. Patients with mental disorders due to brain injury or dysfunction or somatic illness. Patients with mental and behavioral disorders due to psychoactive substance use (alcohol, drugs, multiple drugs or other substances). Patients with altered renal or hepatic function. Pregnant women, nursing mothers, pregnant or not using effective contraception [IUDs in use at least 30 days before the start of the study, barrier methods (diaphragm plus spermicide, condom plus spermicide) to use at least 14 days before the start of the study or hormonal methods (oral contraceptives, implants)]. Patients resistant to treatment with the use of 2 or 3 SSRIs, MAOIs or TCAs at doses established and during the stipulated time. Patients requiring further treatment with use of psychotropic drugs, psychotherapeutic techniques such as general psychotherapy, cognitive-behavioral techniques, predisposition modification techniques, psychotherapy or other specific technical brief psychotherapy. Patients with hypersensitivity to sertraline. Patients who have failed to have been treated with sertraline on a previous occasion. Patients who have been participating in a clinical trial within 30 days prior to inclusion. Patients with unstable medical condition. Patients withconcomitant diseases requiring treatment with any of the following medications: MAOIs, lithium, warfarin, digitoxin, intravenous diazepam and tricyclic antidepressants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Cuba
Contacts
Public ContactYudexi Mendoza Garcia
National Coordinating Center of Clinical trials (CENCEC)
Outcome results
None listed