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| Name | Class |
|---|---|
| Combined Military Hospital Nowshera | OTHER_GOV |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| SSRI Group | Active Comparator | Participants will receive an SSRI at standard therapeutic doses, administered orally for 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Remission Rate | Proportion of participants achieving remission, defined as a depression rating scale score below the clinical threshold. | 6 weeks |
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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Combined Military Hospital | Nowshera | KPK | 25770 | Pakistan | ||
| Department of Psychiatry, Combined Military Hospital Nowshera |
Individual participant data will not be shared due to confidentiality concerns and lack of infrastructure for data sharing.
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D017367 | Selective Serotonin Reuptake Inhibitors |
| ID | Term |
|---|---|
| D014179 | Neurotransmitter Uptake Inhibitors |
| D049990 | Membrane Transport Modulators |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
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| SSRIs | Drug | Participants will receive an SSRI at standard therapeutic doses, administered orally for 6 weeks. |
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| Nowshera |
| KPK |
| 25770 |
| Pakistan |
| D020164 | Chemical Actions and Uses |
| D018377 | Neurotransmitter Agents |
| D018490 | Serotonin Agents |
| D045505 | Physiological Effects of Drugs |