Health Condition 1: F321- Major depressive disorder, singleepisode, moderate
Conditions
Interventions
Intervention1: Dextromethorphan+Bupropion FDC as an Add on therapy: intervention will be given for 6 weeks from baseline First 3 days it will be once a day oral tablet After 3 days twice a day orally
Sponsors
Jay Patel
Eligibility
Inclusion criteria
Inclusion criteria: Diagnosed with Major Depressive Disorder as per DSM 5 criteria. Patients with first episode or recurrent MDD who are either treatment na ve or have remained off antidepressant medication for a minimum period of 4 weeks prior to enrolment. Willing and able to provide written informed consent in patients preferred language Able to understand and comply with the study procedures and scheduled follow up visits
Exclusion criteria
Exclusion criteria: Patients not fulfilling DSM 5 diagnostic criteria for Major Depressive Disorder including those with a history of bipolar disorder mania hypomania psychotic disorders or Major Depressive Disorder with psychotic features High suicide risk clinical judgment of significant suicidal ideation or intent Pregnant or lactating women Patients with moderate to severe hepatic or renal impairment AST or ALT more than 120 and eGFR less than 60 mL per min per 1.73m Known hypersensitivity or contraindication to bupropion dextromethorphan or any Standard treatment of MDD Concomitant use of Monoamine Oxidase Inhibitors or within 14 days of discontinuation Patients who have received Electroconvulsive Therapy or repetitive Transcranial Magnetic Stimulation in the past 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the mean change in Montgomery- sberg Depression Rating Scale score from baseline to week 6 between two treatment groupsTimepoint: from baseline to week 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the mean change in Hamilton Depression Rating Scale from baseline to weeks 2 4 and 6 between the two treatment groupsTimepoint: at 2 4 and 6 weeks;To determine and compare the incidence type severity and frequency of adverse drug reactions between the Dextromethorphan Bupropion and the placebo as an Add on therapyTimepoint: ADRs will be recorded on Day 2 4 and 7 as well as on week 2 4 and 6 | — |
Countries
India
Contacts
Public ContactJAY PATEL
Zydus Medical College & Hospital, Dahod, 389151, Gujarat
Outcome results
None listed