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

Not Applicable

Active, not recruiting

• Conditions: Major Depressive Disorder (MDD)
• Interventions: Drug: Dextromethorphan-Bupropion; Drug: SSRIs

• Registration Number: NCT06957223
• Lead Sponsor: Asad Ullah Jan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-26
• Study First Submitted QC: 2025-04-26
• Study First Posted: 2025-05-04
• Study Start: 2025-05-06
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-04
• Last Update Posted: 2025-07-09
• Primary Completion: 2025-11-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dextromethorphan-Bupropion Group	Dextromethorphan-Bupropion	Participants will receive a fixed-dose combination of dextromethorphan-bupropion, dosed according to approved guidelines for major depressive disorder, administered orally for 6 weeks.
SSRI Group	SSRIs	Participants will receive an SSRI at standard therapeutic doses, administered orally for 6 weeks.

Primary Outcome Measures

Name	Time	Method
Change in Depression Severity (measured by HAMD-17)	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 Outcome Measures

Name	Time	Method
Remission Rate	6 weeks	Proportion of participants achieving remission, defined as a depression rating scale score below the clinical threshold.

Trial Locations

Locations (2)

Combined Military Hospital; 🇵🇰 Nowshera, KPK, Pakistan

Department of Psychiatry, Combined Military Hospital Nowshera; 🇵🇰 Nowshera, KPK, Pakistan

Combined Military Hospital

🇵🇰Nowshera, KPK, Pakistan

Asad Jan

Contact

0092923610029

asad2097@gmail.com