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Study to compare Dextromethorphan-Bupropion and Desvenlafaxine in Patients with Major Depressive Disorder

Prospective, Observational study on Efficacy and Safety of Dextromethorphan-Bupropion in Comparison to Desvenlafaxine in Patients with Major Depressive Disorder - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/01/100712
Enrollment
128
Registered
2026-01-09
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F321- Major depressive disorder, singleepisode, moderate

Interventions

Intervention1: Dextromethorphan-Bupropion: Dextromethorphan-Bupropion (45mg-105mg) per oral for 12weeks Control Intervention1: Desvenlafaxine: Desvenlafaxine (50mg/100mg) per oral for 12weeks

Sponsors

SMS multispecialty hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Patients with age of 18 to 60 years. 2 Patients with first episode of Major Depressive Disorder 3 Scores of MADRS more than 19. 4 Patients with MDD who will be prescribed Desvenlafaxine or Dextromethorphan-Bupropion. 5 The participants who will provide written informed consent

Exclusion criteria

Exclusion criteria: 1. Non-consent for participation in the study 2.Age less than 18 years and more than 60 year. 3. Primary diagnosis of any ANXIETY DISORDER (GAD), SOCIAL ANXIETY DISORDER, PANIC DISORDER, PTSD, SUBSTANCE USE DISORDER, BIPOLAR DISORDER, current or past comorbid diagnosis of SCHIZOPHRENIA, SCHIZOAFFECTIVE DISORDER, DELUSIONAL DISORDER, PSYCHOTIC DISORDER not otherwise specified, ORGANIC MENTAL DISORDER including DEMENTIA, EATING DISORDER, OCD, SEIZURE DISORDER, comorbid serious comorbid condition hypo or hyperthyroidism. 4.Patients with Risk for suicide 5.Patients who are not on drug Dextromethorphan- Bupropion or drug Desvenlafaxine. 6. Patient with clinically significant condition, pulmonary, central nervous system (stroke, dementia), uncontrolled hypertension and Diabetes at screening, renal disease 7.Patients with cardiac condition in the last six months (including but not limited to the, myocardial infarction, moderate to severe congestive heart failure, congenital prolongation of QT, symptomatic bradycardia, Bazett s corrected QT (more than 460msec if male or more than 470msec if female) 8. Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
To study safety and efficacy and Safety of Dextromethorphan-Bupropion in Comparison to Desvenlafaxine in Patients with Major Depressive DisorderTimepoint: baseline, 2nd, 4th ,6th and 12th week.—

Secondary

MeasureTime frame
NILTimepoint: NIL—

Countries

India

Contacts

Public ContactDr Thakur Sakshi Maliksingh

Dr. M.K Shah medical college and research centre

hod_psychiatry@mkshahmcrc.com9228249767

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026