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

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) to evaluate the tolerability of bupropion hydrochloride extended release (Wellbutrin XL®) in patients with MDD with atypical features.

Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Drug: Bupropion extended release Phase 4

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Primary Completion Date : July 2011
Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Wellbutrin XL Drug: Bupropion extended release
300mg once a daily, PO, 8weeks
Other Name: Wellbutrin XL

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. Tolerability [ Time Frame: 8 weeks ]
    Tolerability evaluations will be determined by TEAEs(treatment-emergent adverse events) and vital signs recording.

  3. 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

  4. SDS(Zung Self-Rating Depression Scale) [ Time Frame: 8 weeks ]
    Change of SDS from baseline to end of treatment.

  5. 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.

  6. ESQ(Epworth Sleepiness Questionnaire) [ Time Frame: 8 weeks ]
    Change of ESQ from baseline to end of treatment.

  7. 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.

  8. Remission [ Time Frame: 8 weeks ]
    Remission will be defined as a HAM-D-29 score of ≤ 7.

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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
Sponsors and Collaborators
Chi-Un Pae
Principal Investigator: Chi-Un Pae, MD Department of Psychiatry, Bucheon St.Mary's Hospital

Responsible Party: Chi-Un Pae, Chi-Un Pae MD, phD, Department of Psychiatry, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT01477931     History of Changes
Other Study ID Numbers: 114003
First Posted: November 23, 2011    Key Record Dates
Last Update Posted: November 23, 2011
Last Verified: November 2011

Keywords provided by Chi-Un Pae, The Catholic University of Korea:
Bupropion hydrochloride extended release
Wellbutrin XL
Major Depressive Disorder with Atypical Features

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors