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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
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Chi-Un Pae, The Catholic University of Korea

November 16, 2011
November 23, 2011
November 23, 2011
November 2010
July 2011   (Final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
  • 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.
Same as current
Not Provided
Not Provided
 
Interventional Study of Wellbutrin XL in Major Depressive Disorder With Atypical Features
An Open-Label, 8-week Trial of Bupropion Hydrochloride Extended Release (Wellbutrin XL®) In Patients With Major Depressive Disorder (MDD) With Atypical Features.
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.
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Depressive Disorder, Major
Drug: Bupropion extended release
300mg once a daily, PO, 8weeks
Other Name: Wellbutrin XL
Experimental: Wellbutrin XL
Intervention: Drug: Bupropion extended release
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
Same as current
September 2011
July 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age over 20 years
  • DSM-IV episode of MDD non-psychotic with atypical features characterized by mood reactivity and 2 or more symptoms of vegetative reversal (including overeating, oversleeping, severe fatigue or leaden paralysis, and a history of rejection sensitivity)
  • More than 19 score on the 29-item HAM-D
  • Ability to give informed consent

Exclusion Criteria:

  • Bipolar depression
  • Any Axis I psychotic disorder
  • A history of suicide attempt, self-injurious action (excluding action with no intention of suicide) or overdosage (excluding apparently accidental overdosage)
  • Patients with more than 3-point score of suicide (HAM-D-29 Item 18) or patients whose C-SSRS assessment suggests that they are or have been at significant risk for harming themselves or have actually harmed themselves, or who, in the opinion of the investigator (sub-investigator), are at significant risk for harming self or others
  • A history of substance abuse in the previous 12 months
  • A history of hypersensitivity to bupropion or any other components of the preparations used in the study (Wellbutrin SR 150mg and Wellbutrin XL 300 mg tablets)
  • Serious or unstable medical disorders
  • Starting or terminating psychotherapy during the previous 12 weeks,
  • ECT treatment in the previous 3 months
  • Subject has a life time diagnosis of anorexia nervosa or bulimia within the past 12 month
  • Subject has a current or history of seizure disorder or brain injury (traumatic or disease-related) or any condition which predisposes to seizure- subject treated with other medications or treatment regimens that lower seizure threshold- subject undergoing abrupt discontinuation of alcohol or sedatives
  • Subjects that previously failed adequate courses of pharmacotherapy from two different classes of antidepressants or previous adequate course(s) of bupropion
  • Pregnancy or planning pregnancy - when a patient is in active reproductive age, he or she has to agree to use relevant contraception during the study
  • Patients on monoamine oxidase inhibitors (MAOIs)
  • Patients being treated with any other preparations containing bupropion as the incidence of seizures is dose dependent
Sexes Eligible for Study: All
20 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01477931
114003
No
Not Provided
Not Provided
Chi-Un Pae, The Catholic University of Korea
Chi-Un Pae
GlaxoSmithKline
Principal Investigator: Chi-Un Pae, MD Department of Psychiatry, Bucheon St.Mary's Hospital
The Catholic University of Korea
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP