Interventional Study of Wellbutrin XL in Major Depressive Disorder With Atypical Features (WellbutrinXL)

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Chi-Un Pae, The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT01477931
First received: November 16, 2011
Last updated: November 22, 2011
Last verified: November 2011
  Purpose

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 Intervention Phase
Depressive Disorder, Major
Drug: Bupropion extended release
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by The Catholic University of Korea:

Primary Outcome Measures:
  • HAM-D-29 scores(Hamilton Depression Rating Scale 29) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Changes in HAM-D-29 scores from baseline to the end of treatment.


Secondary Outcome Measures:
  • 8-atypical items on the HAM-D-29 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    8-atypical items on the HAM-D-29 from baseline to end of treatment.

  • Tolerability [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Change of C-SSRS from baseline to end of treatment.

  • ESQ(Epworth Sleepiness Questionnaire) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Change of ESQ from baseline to end of treatment.

  • Response [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Remission will be defined as a HAM-D-29 score of ≤ 7.


Enrollment: 50
Study Start Date: November 2010
Study Completion Date: September 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Wellbutrin XL Drug: Bupropion extended release
300mg once a daily, PO, 8weeks
Other Name: Wellbutrin XL

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01477931

Locations
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
GlaxoSmithKline
Investigators
Principal Investigator: Chi-Un Pae, MD Department of Psychiatry, Bucheon St.Mary's Hospital
  More Information

No publications provided

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
Study First Received: November 16, 2011
Last Updated: November 22, 2011
Health Authority: Korea: Institutional Review Board

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

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Disease
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pathologic Processes
Bupropion
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014