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A study to compare the effect of a new medicine (Bupropion-Dextromethorphan) with that of an old medicine (Sertraline) in improving depressive symptoms in persons suffering from depression.

Efficacy of Bupropion-Dextromethorphan fixed dose combination versus Sertraline in major depressive disorder patients: a non-inferiority randomised controlled trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/09/073493
Enrollment
80
Registered
2024-09-05
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Health Condition 1: F322- Major depressive disorder, singleepisode, severe without psychotic features

Interventions

Intervention1: Bupropion (105 mg) Dextromethorphan (45 mg) fixed dose combination: 105 mg/45 mg drug per oral once daily for initial three days followed by twice daily for 6 weeks Control Intervention

Sponsors

All India Institute of Medical Sciences Patna
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Falling into age range of 18-65 years. 2. Confirmed MDD (DSM-5 criteria) patient experiencing a major depressive episode for at least 4 weeks. 3. Baseline MADRS score of 20 or higher, corresponding to moderate or greater severity and CGI-S of 4 or higher. 4. Ability to provide informed consent

Exclusion criteria

Exclusion criteria: 1. Patients with treatment resistant depression (at least two failed treatments in the current depressive episode). 2. Patients receiving treatment for Psychotic Disorder, Bipolar Disorder, Panic Disorder, Obsessive compulsive Disorder or Seizure Disorder. 3. Current Alcohol or substance use or dependence within the past 12 months. 4. Any patient with high risk of suicide. 5. Medical conditions: presence of severe medical or neurological conditions. 6. Pregnant woman or Breastfeeding mother. 7. Allergy to any of the components of study drug(s).

Design outcomes

Primary

MeasureTime frame
Proportion of participants responding based on a predefined change in MADRS score at 6 weeks of therapy.Timepoint: 6 weeks—

Secondary

MeasureTime frame
Secondary outcomes Change in MADRS score at 6 weeks of therapy Time to achieve 50% reduction in MADRS score Change in score/ Proportion of participants responding clinically based on a predefined criteria of change in score of CGI-S Improvement in disease condition based on CGI-I Number of adverse events during study follow-up Proportion of participants responding clinically based on a predefined criteria of change in score of Q-LES-QSFTimepoint: 6 weeks—

Countries

India

Contacts

Public ContactDr Vikas Maharshi

AIIMS, Patna

vikas.maharshi81@gmail.com8368035562

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026