Interventional Study of Wellbutrin XL in Major Depressive Disorder With Atypical Features (WellbutrinXL)
|ClinicalTrials.gov Identifier: NCT01477931|
Recruitment Status : Completed
First Posted : November 23, 2011
Last Update Posted : November 23, 2011
|Condition or disease||Intervention/treatment||Phase|
|Depressive Disorder, Major||Drug: Bupropion extended release||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, 8-week Trial of Bupropion Hydrochloride Extended Release (Wellbutrin XL®) In Patients With Major Depressive Disorder (MDD) With Atypical Features.|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||September 2011|
|Experimental: Wellbutrin XL||
Drug: Bupropion extended release
300mg once a daily, PO, 8weeks
Other Name: Wellbutrin XL
- HAM-D-29 scores(Hamilton Depression Rating Scale 29) [ Time Frame: 8 weeks ]Changes in HAM-D-29 scores from baseline to the end of treatment.
- 8-atypical items on the HAM-D-29 [ Time Frame: 8 weeks ]8-atypical items on the HAM-D-29 from baseline to end of treatment.
- Tolerability [ Time Frame: 8 weeks ]Tolerability evaluations will be determined by TEAEs(treatment-emergent adverse events) and vital signs recording.
- CGI-I score(Clinical Global Impression Improvement score) [ Time Frame: 8 weeks ]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
- SDS(Zung Self-Rating Depression Scale) [ Time Frame: 8 weeks ]Change of SDS from baseline to end of treatment.
- C-SSRS(The Columbia-Suicide Severity Rating Scale, changes in behaviours and ideation) [ Time Frame: 8 weeks ]Change of C-SSRS from baseline to end of treatment.
- ESQ(Epworth Sleepiness Questionnaire) [ Time Frame: 8 weeks ]Change of ESQ from baseline to end of treatment.
- Response [ Time Frame: 8 weeks ]Response will be defined as 50% or greater reduction in HAM-D-29 scores from baseline to end of treatment.
- Remission [ Time Frame: 8 weeks ]Remission will be defined as a HAM-D-29 score of ≤ 7.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01477931
|Korea, Republic of|
|Korea University Ansan Hospital|
|Ansan, Gyeonggi-Do, Korea, Republic of, 425-707|
|Bucheon St.Mary's Hospital|
|Bucheon, Gyeonggi-do, Korea, Republic of, 150-713|
|The Catholic University of Korea, St.Vincent Hospital|
|Suwon, Gyeonggi-do, Korea, Republic of, 442-723|
|The Catholic University of Korea, Uijeongbu St. Mary'S Hospital|
|Uijeongbu, Gyeonggi-do, Korea, Republic of, 480-717|
|dongguk university MEDICAL CENTER|
|Kyungju, Kyoung-Book, Korea, Republic of, 780-350|
|Kyung Hee University Hospital|
|Seoul, Korea, Republic of, 130-702|
|Principal Investigator:||Chi-Un Pae, MD||Department of Psychiatry, Bucheon St.Mary's Hospital|