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

NCT06957223 | Active Not Recruiting

• 1 other identifier: CMHNSR-REF-16
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Major Depressive Disorder (MDD)

Outcome Measures

Primary Outcomes (1)

• Change in Depression Severity (measured by HAMD-17)

  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).

  6 weeks

Secondary Outcomes (1)

• Remission Rate

  6 weeks

Study Arms (2)

Dextromethorphan-Bupropion Group

EXPERIMENTAL

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

Drug: Dextromethorphan-Bupropion

SSRI Group

ACTIVE COMPARATOR

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

Drug: SSRIs

Interventions

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.

Dextromethorphan-Bupropion Group

SSRIs DRUG

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

SSRI Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asad Ullah Jan: lead
• CMH Nowshera: collaborator

Study Sites (2)

Combined Military Hospital

Nowshera, KPK, 25770, Pakistan

Location

Department of Psychiatry, Combined Military Hospital Nowshera

Nowshera, KPK, 25770, Pakistan

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Selective Serotonin Reuptake Inhibitors

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head Department of Psychiatry

Study Record Dates

• First Submitted: April 26, 2025
• First Posted: May 4, 2025
• Study Start: May 6, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 31, 2025
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)