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| ID | Type | Description | Link |
|---|---|---|---|
| GSK IIT |
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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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The current study is being conducted in patients with major depression. The study aims to 1) investigate the combined effects of selective serotonin reuptake inhibitor (SSRI) and bupropion compared to SSRI alone on the improvements of depressive symptoms, fatigue, hypersomnia, and neurocognitive functions, 2) observe structural/functional/chemical changes using magnetic resonance imaging (MRI), 3) and examine a relationship between the improvements of depressive symptoms, fatigue, and hypersomnia and the neural changes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Escitalopram + Bupropion | Experimental |
| |
| Escitalopram | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupropion, Escitalopram | Drug | Week 0-1: Escitalopram 10mg, Bupropion 150mg Week 2-3: Escitalopram 10mg, Bupropion 300mg Week 4-8: Escitalopram 20mg, Bupropion 300mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Depressive Symptom Scores at 8 Weeks | Baseline and at 8 Weeks | |
| Change from Baseline in Depressive Symptom Scores at 4 Weeks | Baseline and at 4 Weeks | |
| Change from Baseline in Depressive Symptom Scores at 1 Week | Baseline and at 1 Week |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events | 1 Week | |
| Change from Baseline in Neurocognitive Function as Expressed as Z Scores Transformed Using the Control Group Mean and Distribution Values at 8 Weeks | Baseline and 8 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| In Kyoon Lyoo, MD, PhD, MMS | Ehwa W. univ hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital, Biomedical Research Institute | Seoul | Seoul | 110-744 | South Korea |
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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 |
|---|---|
| D016642 | Bupropion |
| D000089983 | Escitalopram |
| ID | Term |
|---|---|
| D011427 | Propiophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
| D011437 | Propylamines |
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| Escitalopram | Drug | Week 0-3: Escitalopram 10mg Week 4-8: Escitalopram 20mg |
|
| Changes from Baseline in Brain Structure and Function, Analyzed Using the Computational Approach | Baseline and 8 Weeks |
| Number of Participants with Adverse Events | 4 Weeks |
| Number of Participants with Adverse Events | 8 Weeks |
| Changes in Fatigue Severity Scale scores | Week 8 |
| D000588 |
| Amines |
| D009570 | Nitriles |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |