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

Overview

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.

Full Title of Study: “An Open-Label, 8-week Trial of Bupropion Hydrochloride Extended Release (Wellbutrin XL®) In Patients With Major Depressive Disorder (MDD) With Atypical Features.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2011

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.

Interventions

  • Drug: Bupropion extended release
    • 300mg once a daily, PO, 8weeks

Arms, Groups and Cohorts

  • Experimental: Wellbutrin XL

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chi-Un Pae
  • Collaborator
    • GlaxoSmithKline
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Chi-Un Pae, Chi-Un Pae MD, phD, Department of Psychiatry – The Catholic University of Korea
  • Overall Official(s)
    • Chi-Un Pae, MD, Principal Investigator, Department of Psychiatry, Bucheon St.Mary’s Hospital

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