Status:
COMPLETED
Interventional Study of Wellbutrin XL in Major Depressive Disorder With Atypical Features
Lead Sponsor:
Chi-Un Pae
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Depressive Disorder, Major
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief Summary
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) t...
Detailed Description
Whether bupropion hydrochloride extended release (Wellbutrin XL®) improved atypical depressive symptoms has not been investigated. The investigators assumed that bupropion hydrochloride extended relea...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01477931
Start Date
November 1 2010
End Date
September 1 2011
Last Update
November 23 2011
Active Locations (6)
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1
Korea University Ansan Hospital
Ansan, Gyeonggi-do, South Korea, 425-707
2
Bucheon St.Mary's Hospital
Bucheon-si, Gyeonggi-do, South Korea, 150-713
3
The Catholic University of Korea, St.Vincent Hospital
Suwon, Gyeonggi-do, South Korea, 442-723
4
The Catholic University of Korea, Uijeongbu St. Mary'S Hospital
Uijeongbu-si, Gyeonggi-do, South Korea, 480-717