Interventional Study of Wellbutrin XL in Major Depressive Disorder With Atypical Features
NCT ID: NCT01477931
Last Updated: 2011-11-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
50 participants
INTERVENTIONAL
2010-11-30
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Wellbutrin XL
Bupropion extended release
300mg once a daily, PO, 8weeks
Interventions
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Bupropion extended release
300mg once a daily, PO, 8weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Chi-Un Pae
OTHER
Responsible Party
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Chi-Un Pae
Chi-Un Pae MD, phD, Department of Psychiatry
Principal Investigators
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Chi-Un Pae, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Psychiatry, Bucheon St.Mary's Hospital
Locations
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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
dongguk university MEDICAL CENTER
Kyungju, Kyoung-Book, South Korea
Kyung Hee University Hospital
Seoul, Seoul, South Korea
Countries
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Other Identifiers
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114003
Identifier Type: -
Identifier Source: org_study_id