Health Condition 1: F321- Major depressive disorder, singleepisode, moderate
Conditions
Interventions
Intervention1: DRUG: DEXTROMETHORPHAN BUPROPION
Control Intervention1: DRUG: ESCITALOPRAM
Sponsors
TEJASWI P
Eligibility
Inclusion criteria
Inclusion criteria: 1 Patients willing to give written informed consent 2 Newly diagnosed patients with major depressive disorder of either sex aged between 18 and 65 years and a current episode of major depressive disorder 3 Diagnosis will be made based on DSM 5 criteria 4 A minimum score of more than or equal to 25 on Montgomery-Asberg depression rating scale MADRS 5 Minimum score of more than or equal to 4 on clinical global impression severity scale CGI S
Exclusion criteria
Exclusion criteria: 1 Pregnant or lactating females 2 Patients with medical conditions like hepatic or renal failure 3 Past history of any cardiac disease 4 History of bipolar disorder 5 History of panic disorder 6 History of obsessive compulsive disorder 7 History of treatment resistance depression defined as having at least two failed adequate antidepressants treatments in current major depressive episode 8 History of psychotic disorder 9 Clinically risk of suicide assessed by C SSRS 10 History of seizures 11 Patients on treatment with any other drugs which are CYP2D6 inducers or inhibitors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy variable will be the change in MADRS total score from baseline to week 6Timepoint: 6 WEEKS | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Reduction more than or equal to 50% from baseline in MADRAS total score known as clinical response 2 MADRS total score less than or equal to 10 known as clinical remission 3 Score on clinical global impression severity scale 4 Score on clinical global impression improvement scale 5 Quick inventory of depression symptomology score known as QIDS SR scoreTimepoint: 6 weeks | — |
Countries
India
Contacts
Public ContactDr VIJAYAKUMAR A E
ESIC MEDICAL COLLEGE AND PGIMSR
Outcome results
None listed