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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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The aims of this study are 1) to examine the clinical utility of bupropion hydrochloride extended release (Wellbutrin XL®) in patients with Major Depressive Disorder (MDD) with atypical features; 2) to evaluate the tolerability of bupropion hydrochloride extended release (Wellbutrin XL®) in patients with MDD with atypical features.
Whether bupropion hydrochloride extended release (Wellbutrin XL®) improved atypical depressive symptoms has not been investigated. The investigators assumed that bupropion hydrochloride extended release (Wellbutrin XL®) will be effective and tolerable in the treatment of atypical depression in MDD patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wellbutrin XL | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupropion extended release | Drug | 300mg once a daily, PO, 8weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| HAM-D-29 scores(Hamilton Depression Rating Scale 29) | Changes in HAM-D-29 scores from baseline to the end of treatment. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 8-atypical items on the HAM-D-29 | 8-atypical items on the HAM-D-29 from baseline to end of treatment. | 8 weeks |
| Tolerability | Tolerability evaluations will be determined by TEAEs(treatment-emergent adverse events) and vital signs recording. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chi-Un Pae, MD | Department of Psychiatry, Bucheon St.Mary's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Ansan Hospital | Ansan | Gyeonggi-do | 425-707 | South Korea | ||
| Bucheon St.Mary's Hospital |
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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 |
| ID | Term |
|---|---|
| D011427 | Propiophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
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| 8 weeks |
| CGI-I score(Clinical Global Impression Improvement score) | CGI-I score of 1 or 2 (proportion of the patients achieving this point at the end of treatment) or changes in total scores on CGI-S | 8 weeks |
| SDS(Zung Self-Rating Depression Scale) | Change of SDS from baseline to end of treatment. | 8 weeks |
| C-SSRS(The Columbia-Suicide Severity Rating Scale, changes in behaviours and ideation) | Change of C-SSRS from baseline to end of treatment. | 8 weeks |
| ESQ(Epworth Sleepiness Questionnaire) | Change of ESQ from baseline to end of treatment. | 8 weeks |
| Response | Response will be defined as 50% or greater reduction in HAM-D-29 scores from baseline to end of treatment. | 8 weeks |
| Remission | Remission will be defined as a HAM-D-29 score of ≤ 7. | 8 weeks |
| Bucheon-si |
| Gyeonggi-do |
| 150-713 |
| South Korea |
| The Catholic University of Korea, St.Vincent Hospital | Suwon | Gyeonggi-do | 442-723 | South Korea |
| The Catholic University of Korea, Uijeongbu St. Mary'S Hospital | Uijeongbu-si | Gyeonggi-do | 480-717 | South Korea |
| dongguk university MEDICAL CENTER | Kyungju | Kyoung-Book | 780-350 | South Korea |
| Kyung Hee University Hospital | Seoul | Seoul | 130-702 | South Korea |