Interventional Study of Wellbutrin XL in Major Depressive Disorder With Atypical Features (WellbutrinXL)
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|