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

Sponsor

Chi-Un Pae (Other)

Overall Status

Completed

CT.gov ID

NCT01477931

Collaborator

GlaxoSmithKline (Industry)

Enrollment

Locations

Arm

Duration (Months)

8.3

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

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.

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 Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

N/A

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 :

Nov 1, 2010

Actual Primary Completion Date :

Jul 1, 2011

Actual Study Completion Date :

Sep 1, 2011

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Wellbutrin XL

Drug: Bupropion extended release

300mg once a daily, PO, 8weeks

Other Names:

Wellbutrin XL

Outcome Measures

Primary Outcome Measures

HAM-D-29 scores(Hamilton Depression Rating Scale 29) [8 weeks]
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 weeks]
8-atypical items on the HAM-D-29 from baseline to end of treatment.
Tolerability [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) [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) [8 weeks]
Change of SDS from baseline to end of treatment.
C-SSRS(The Columbia-Suicide Severity Rating Scale, changes in behaviours and ideation) [8 weeks]
Change of C-SSRS from baseline to end of treatment.
ESQ(Epworth Sleepiness Questionnaire) [8 weeks]
Change of ESQ from baseline to end of treatment.
Response [8 weeks]
Response will be defined as 50% or greater reduction in HAM-D-29 scores from baseline to end of treatment.
Remission [8 weeks]
Remission will be defined as a HAM-D-29 score of ≤ 7.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Korea University Ansan Hospital	Ansan	Gyeonggi-Do	Korea, Republic of	425-707
2	Bucheon St.Mary's Hospital	Bucheon	Gyeonggi-do	Korea, Republic of	150-713
3	The Catholic University of Korea, St.Vincent Hospital	Suwon	Gyeonggi-do	Korea, Republic of	442-723
4	The Catholic University of Korea, Uijeongbu St. Mary'S Hospital	Uijeongbu	Gyeonggi-do	Korea, Republic of	480-717
5	dongguk university MEDICAL CENTER	Kyungju	Kyoung-Book	Korea, Republic of	780-350
6	Kyung Hee University Hospital	Seoul		Korea, Republic of	130-702