Major Depressive Disorder (MDD)
Conditions
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.
Interventions
Participants will receive a fixed-dose combination of dextromethorphan-bupropion, dosed according to approved guidelines for major depressive disorder, administered orally for 6 weeks.
DRUGSSRIs
Participants will receive an SSRI at standard therapeutic doses, administered orally for 6 weeks.
Sponsors
Asad Ullah Jan
Combined Military Hospital Nowshera
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Remission Rate | 6 weeks | Proportion of participants achieving remission, defined as a depression rating scale score below the clinical threshold. |
Countries
Pakistan
Outcome results
None listed