None listed
Conditions
Interventions
GROUP 1 Type of group
Acute Phase: This group will be treated with Desvenlafaxine, in 50 or 100 mg tablets, at a dose of 50 mg, on days 1 to 7, and a dose of 100 mg, on days 8 to 57. The medication will be administered in a oral, QD. Continuation Phase: Subjects with a positive response to treatment will continue with the same therapy for 6 months. Those subjects with an inadequate response to treatment will switch to Desvenlafaxine, in tablets, at a dose of 100 mg, PO, QD openly for 6 months Phase of Gradual Discont
Acute Phase: This group will be treated with Escitalopram, in 10 mg tablets, at a dose of 10 mg, PO, QD, for 57 days. Continuation Phase: Subjects with a positive response to treatment will continue with the same therapy for 6 months. Those subjects with an inadequate response to treatment will switch to Desvenlafaxine, in tablets, at a dose of 100 mg, PO, QD openly for 6 months. Phase of Gradual Discontinuation: The dose of the medication will be reduced gradually, during approximately 3 weeks.
Sponsors
LABORATORIOS WYETH S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Postmenopausal women between 40 and 70 years of age. 2. Postmenopausal state determined by, at least, 6 to 12 consecutive months of spontaneous amenorrhea and FSH levels> 40, or 6 months post-surgical to a bilateral oophorectomy. 3. Main diagnosis of MDD based on the criterion of the Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV), single or recurrent episode. 4. Symptoms of depression for at least 30 days before the screening visit. 5. A total score of ≥ 22 on the MADRS scale at the screening and baseline visits, and no more than 5 improvement points from the screening visit to the baseline visit.
Exclusion criteria
Exclusion criteria: 1. Previous treatment with DVS SR in the past. 2. Known hypersensitivity to venlafaxine immediate release (IR) or extended release (ER), desvenlafaxine SR or escitalopram. 3. Intolerance or failure of previous treatment with escitalopram. 4. Significant risk of suicide or being potentially violent to oneself or to others, based on the clinical judgment of the investigator. 5. Current abuse or dependence on psychoactive substances, manic episodes, post-traumatic stress disorders, obsessive-compulsive disorders, or life-long diagnosis of bipolar or psychotic disorder. 6. Presence of a clinically important personality disorder. 7. Formal cognitive therapy (CBT) or interpersonal therapy (IPT) within the previous 30 days. 8. Depression associated with the presence of mental disorder due to a general clinical condition or neurological disorder. 9. History of seizures, in addition to isolated febrile seizures of childhood that were completely resolved. 10. Any hepatic, renal, pulmonary, cardiovascular, ophthalmological, neurological instability, or any other medical condition that may confuse the study or expose the subject to greater risks. 11. History or current evidence of known gastrointestinal disease or surgical history that may interfere with the absorption and excretion of drugs. 12. History of neoplastic disorders. 13. Known presence of elevated intraocular pressure or history of narrow-angle glaucoma. 14. Myocardial infarction within 6 months of the screening visit. 15. Important abnormalities from the clinical point of view. 16. Use of injectable progesterone or estrogen implants within 3 months prior to the baseline visit. 17. Use of vaginal hormone products within 4 weeks prior to the baseline visit. 18. Oral use of estrogen, progesterone, androgens or products containing SERM, phytoestrogens, transdermal hormone products or intrauterine progesterone within the previous 8 weeks. 19. Use of injectable estrogen or progesterone pills within the previous 6 months. 20. Use of hypnotic sedatives; herbal products to treat anxiety, insomnia and depression; serotonin precursors; other drugs or psychotropic substances; non-psychopharmacological drugs with psychotropic effects 7 days prior to the baseline visit. 21. Use of monoamine oxidase inhibitors within the previous 30 days. 22. Use of anxiolytics; sumatriptan, naratriptan, zolmitriptan; or antidepressants at least 7 days before. 23. Use of any drug or procedure under investigation, antipsychotics or fluoxetine within 30 days prior. 24. Electroconvulsive therapy or formal psychotherapy within 6 months of the baseline visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The Psychiatric Rating Scale for Depression of Hamilton, is a scale of 17 items, administered by the doctor, which evaluates the symptom profile associated with severe depressive disorder. Measure:Change in the total score HAM-D17. Timepoints:Days 1, 7, 14, 21, 28, 42, 56, 63, 70, 84, 126, 154, 182, 210 and 252. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:1) CGI-I: The Global Clinical Improvement Impression Scale, is a self-applied evaluation that evaluates the improvement using a Likert scale of 7 degrees of intensity. 2) CGI-S: The Clinical Global Gravure Impression Scale is an evaluation applied by a physician that evaluates the improvement using a Likert scale of 7 degrees of intensity. 3) MADRS: The Montgomery-Asberg Depression Scale is an evaluation applied by a clinician who evaluates 10 items of the symptom profile associated with severe depressive disorder. 5) HAM-A: The Psychiatric Scale for Hamilton Anxiety is a 14-item evaluation, which evaluates the symptom profile associated with severe anxiety disorder. 6) QIDS-SR: The Rapid Depressive Symptomatology Inventory - Self-applied Report, is a self-applied scale that evaluates 16 items of the symptom profile associated with depression. 7) DESS: Emerging Signs and Symptoms of Discontinuation, is a 43-item evaluation, administered by an observer, which evaluates the discontinuation of symptoms. 8) VAS-PI: Visual Analog Scale of Pain Intensity. Measure:Secondary efficiency: Changes in 1) CGI-I. 2) CGI-S. 3) MADRS. 5) HAM-A. 6) QIDS-SR. 7) DESS. 8) VAS-PI Timepoints:1) CGI-I, CGI-S, MADRS, HAM-A, QIDS-SR and VAS-PI: Days 7, 14, 21, 28, 42, 56, 63, 70, 84, 126, 154, 182, 210 and 252. 2) DESS: Days 63, 154 and 238. ; Outcome name:Criterion 1: Complete physical examination including height and weight of the subject. Criterion 2: Standard ECG, optionally and at the discretion of the researcher. Criterion 3: Panels of hematology and serum chemistry, urinalysis. Criterion 4: The vital signs should be evaluated after the subject has been at rest for at least 10 minutes. These include 2 measurements of blood pressure in the supine position and pulse rate at rest. Criterion 5: Clinical evaluation of any unexpected, unwanted or unplanned event in the form of signs, symptoms, illness, or laboratory or psychological observations that occurs to a | — |
Countries
Argentina, Chile, Colombia, Mexico, Peru, United States
Outcome results
None listed