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Completed

NCT Number: NCT06957223

Efficacy of Dextromethorphan-Bupropion Versus SSRIs in the Treatment of Major Depressive Disorder

The study aims to compare the antidepressant effects of a dextromethorphan-bupropion combination versus standard SSRI therapy in adult patients with major depressive disorder. Participants will be randomized into two groups: one receiving dextromethorphan-bupropion and the other receiving an SSRI (e.g., sertraline or escitalopram). Treatment will last for 6 weeks, with assessments at baseline and study completion. The primary outcome will be the remission rate measured by a validated depression rating scale. Secondary outcomes include change in depressive symptoms severity and safety/tolerability measures.

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Key information

Conditions

Major Depressive Disorder (MDD) Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Combined Military Hospital, Nowshera, KPK, Pakistan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Diagnosed with major depressive disorder (MDD) per DSM-5 criteria.

Baseline depression score indicating moderate to severe depression

Ability to provide informed consent

Willing to comply with study requirements

Exclusion criteria

History of bipolar disorder, schizophrenia, or other psychotic disorders

Current substance use disorder (within past 6 months)

Active suicidal ideation requiring urgent intervention

Pregnancy or breastfeeding

Known hypersensitivity to study medications

Treatment and study plan

Dextromethorphan-Bupropion

Drug

Participants will receive a fixed-dose combination of dextromethorphan-bupropion, dosed according to approved guidelines for major depressive disorder, administered orally for 6 weeks.

SSRIs

Drug

Participants will receive an SSRI at standard therapeutic doses, administered orally for 6 weeks.

Primary outcomes

  1. Change in Depression Severity (measured by HAMD-17)

    Time frame: 6 weeks

    Change from baseline in depressive symptom scores, measured using the Hamilton Depression Rating Scale, 17-item version (HAMD-17; score range 0-52, with higher scores indicating worse depression severity).

Secondary outcomes

  1. Remission Rate

    Time frame: 6 weeks

    Proportion of participants achieving remission, defined as a depression rating scale score below the clinical threshold.

Sponsors and collaborators

Lead sponsor

Asad Ullah Jan

Other Gov

Collaborators

  • Combined Military Hospital Nowshera

Registry information

Official study title

Efficacy of Dextromethorphan-Bupropion Versus SSRIs in the Treatment of Major Depressive Disorder: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 4, 2025
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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