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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
300mg once a daily, PO, 8weeks
Korea University Ansan Hospital
Ansan, Gyeonggi-do, South Korea
Bucheon St.Mary's Hospital
Bucheon-si, Gyeonggi-do, South Korea
The Catholic University of Korea, St.Vincent Hospital
Suwon, Gyeonggi-do, South Korea
The Catholic University of Korea, Uijeongbu St. Mary'S Hospital
Uijeongbu-si, Gyeonggi-do, South Korea
HAM-D-29 scores(Hamilton Depression Rating Scale 29)
Changes in HAM-D-29 scores from baseline to the end of treatment.
Time frame: 8 weeks
8-atypical items on the HAM-D-29
8-atypical items on the HAM-D-29 from baseline to end of treatment.
Time frame: 8 weeks
Tolerability
Tolerability evaluations will be determined by TEAEs(treatment-emergent adverse events) and vital signs recording.
Time frame: 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
Time frame: 8 weeks
SDS(Zung Self-Rating Depression Scale)
Change of SDS from baseline to end of treatment.
Time frame: 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.
Time frame: 8 weeks
ESQ(Epworth Sleepiness Questionnaire)
Change of ESQ from baseline to end of treatment.
Time frame: 8 weeks
Response
Response will be defined as 50% or greater reduction in HAM-D-29 scores from baseline to end of treatment.
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dongguk university MEDICAL CENTER
Kyungju, Kyoung-Book, South Korea
Kyung Hee University Hospital
Seoul, Seoul, South Korea
Time frame: 8 weeks
Remission
Remission will be defined as a HAM-D-29 score of ≤ 7.
Time frame: 8 weeks