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

Primary Purpose

Depressive Disorder, Major

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Bupropion extended release
Sponsored by
Chi-Un Pae
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder, Major focused on measuring Bupropion hydrochloride extended release, Wellbutrin XL, Major Depressive Disorder with Atypical Features

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Korea University Ansan Hospital
  • Bucheon St.Mary's Hospital
  • The Catholic University of Korea, St.Vincent Hospital
  • The Catholic University of Korea, Uijeongbu St. Mary'S Hospital
  • dongguk university MEDICAL CENTER
  • Kyung Hee University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Wellbutrin XL

Arm Description

Outcomes

Primary Outcome Measures

HAM-D-29 scores(Hamilton Depression Rating Scale 29)
Changes in HAM-D-29 scores from baseline to the end of treatment.

Secondary Outcome Measures

8-atypical items on the HAM-D-29
8-atypical items on the HAM-D-29 from baseline to end of treatment.
Tolerability
Tolerability evaluations will be determined by TEAEs(treatment-emergent adverse events) and vital signs recording.
CGI-I score(Clinical Global Impression Improvement score)
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)
Change of SDS from baseline to end of treatment.
C-SSRS(The Columbia-Suicide Severity Rating Scale, changes in behaviours and ideation)
Change of C-SSRS from baseline to end of treatment.
ESQ(Epworth Sleepiness Questionnaire)
Change of ESQ from baseline to end of treatment.
Response
Response will be defined as 50% or greater reduction in HAM-D-29 scores from baseline to end of treatment.
Remission
Remission will be defined as a HAM-D-29 score of ≤ 7.

Full Information

First Posted
November 16, 2011
Last Updated
November 22, 2011
Sponsor
Chi-Un Pae
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT01477931
Brief Title
Interventional Study of Wellbutrin XL in Major Depressive Disorder With Atypical Features
Acronym
WellbutrinXL
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 Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Chi-Un Pae
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major
Keywords
Bupropion hydrochloride extended release, Wellbutrin XL, Major Depressive Disorder with Atypical Features

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wellbutrin XL
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Bupropion extended release
Other Intervention Name(s)
Wellbutrin XL
Intervention Description
300mg once a daily, PO, 8weeks
Primary Outcome Measure Information:
Title
HAM-D-29 scores(Hamilton Depression Rating Scale 29)
Description
Changes in HAM-D-29 scores from baseline to the end of treatment.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
8-atypical items on the HAM-D-29
Description
8-atypical items on the HAM-D-29 from baseline to end of treatment.
Time Frame
8 weeks
Title
Tolerability
Description
Tolerability evaluations will be determined by TEAEs(treatment-emergent adverse events) and vital signs recording.
Time Frame
8 weeks
Title
CGI-I score(Clinical Global Impression Improvement score)
Description
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
Time Frame
8 weeks
Title
SDS(Zung Self-Rating Depression Scale)
Description
Change of SDS from baseline to end of treatment.
Time Frame
8 weeks
Title
C-SSRS(The Columbia-Suicide Severity Rating Scale, changes in behaviours and ideation)
Description
Change of C-SSRS from baseline to end of treatment.
Time Frame
8 weeks
Title
ESQ(Epworth Sleepiness Questionnaire)
Description
Change of ESQ from baseline to end of treatment.
Time Frame
8 weeks
Title
Response
Description
Response will be defined as 50% or greater reduction in HAM-D-29 scores from baseline to end of treatment.
Time Frame
8 weeks
Title
Remission
Description
Remission will be defined as a HAM-D-29 score of ≤ 7.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chi-Un Pae, MD
Organizational Affiliation
Department of Psychiatry, Bucheon St.Mary's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea University Ansan Hospital
City
Ansan
State/Province
Gyeonggi-Do
ZIP/Postal Code
425-707
Country
Korea, Republic of
Facility Name
Bucheon St.Mary's Hospital
City
Bucheon
State/Province
Gyeonggi-do
ZIP/Postal Code
150-713
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, St.Vincent Hospital
City
Suwon
State/Province
Gyeonggi-do
ZIP/Postal Code
442-723
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Uijeongbu St. Mary'S Hospital
City
Uijeongbu
State/Province
Gyeonggi-do
ZIP/Postal Code
480-717
Country
Korea, Republic of
Facility Name
dongguk university MEDICAL CENTER
City
Kyungju
State/Province
Kyoung-Book
ZIP/Postal Code
780-350
Country
Korea, Republic of
Facility Name
Kyung Hee University Hospital
City
Seoul
ZIP/Postal Code
130-702
Country
Korea, Republic of

12. IPD Sharing Statement

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

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