Health Condition 1: F339- Major depressive disorder, recurrent, unspecified
Conditions
Interventions
Intervention1: Vortioxetine: Vortioxetine is a new antidepressant for the treatment of depression which was approved on September 2013 by FDA (Food and drug administration) and May 2018 by DCGI (Drug
Sponsors
Dr Anshul Upadhyay
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with primary diagnosed depression with MADRS (Montgomeryâ??Ã?sberg Depression Rating Scale) score >22 and no other concurrent psychiatric disorders at baseline. 2. Patients of 18 â?? 60 years of age 3. Subjects of either gender 4. Subjects willing to give written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with history of substance abuse. 2. Patients with two failed previous antidepressant treatments (of at least 6 weeks in duration) 3. Patient with any other long-term treatment like anti-hypertensive, anti-diabetic, anti-tubercular 4. Patients with neurological disorders (dementia, stroke, seizures), obesity with functional impairment, serious or not stabilized organic disorder (neoplastic, cardiovascular, pulmonary, uncontrolled diabetes). 5. Patients who pose a significant risk of suicide, had a score of 5 on item 10 (suicidal thoughts) of the MADRS or had made a suicide attempt in the previous 6 months. 6. Patients who have received electroconvulsive therapy in the preceding 6 months. 7. Patients who have MADRS (Montgomeryâ??Ã?sberg Depression Rating Scale) score
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in MADRS (Montgomeryâ??Ã?sberg Depression Rating Scale) score between Vortioxetine group and Escitalopram group at 8 weeksTimepoint: 0 and 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in mean patient weight at 8 weeks in Vortioxetine and Escitalopram groupTimepoint: 0 and 8 weeks;Change in the values of baseline laboratory investigations (Complete blood count, Liver function test, Renal function test) seen after 8th week in Vortioxetine and Escitalopram group. Timepoint: 0 and 8 weeks;Difference in CGI (Clinical Global Impression) score between Vortioxetine group and Escitalopram group at 8 weeksTimepoint: 0 and 8 weeks;Difference in DSST (Digit Symbol Substitution Test) score between Vortioxetine group and Escitalopram group at 8 weeksTimepoint: 0 and 8 week;Difference in HDRS (Hamilton Depression Rating Scale) score between Vortioxetine group and Escitalopram group at 8 weeksTimepoint: 0 and 8 weeks;Difference in PDQ-5 (Perceived deficits questionnaire-5) score between Vortioxetine group and Escitalopram group at 8 weeksTimepoint: 0 and 8 weeks | — |
Countries
India
Contacts
Public ContactDr Anshul Upadhyay
Government Medical College, Nagpur
Outcome results
None listed