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

Depressive Disorder, Major Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01477931
• Other study ID #: 114003
• Status: Completed
• Phase: Phase 4
• First received: November 16, 2011
• Last updated: November 22, 2011
• Start date: November 2010
• Est. completion date: September 2011

Study information

• Verified date: November 2011
• Source: The Catholic University of Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Korea University Ansan Hospital	Ansan	Gyeonggi-Do
Korea, Republic of	Bucheon St.Mary's Hospital	Bucheon	Gyeonggi-do
Korea, Republic of	dongguk university MEDICAL CENTER	Kyungju	Kyoung-Book
Korea, Republic of	Kyung Hee University Hospital	Seoul
Korea, Republic of	The Catholic University of Korea, St.Vincent Hospital	Suwon	Gyeonggi-do
Korea, Republic of	The Catholic University of Korea, Uijeongbu St. Mary'S Hospital	Uijeongbu	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Chi-Un Pae	GlaxoSmithKline

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HAM-D-29 scores(Hamilton Depression Rating Scale 29)	Changes in HAM-D-29 scores from baseline to the end of treatment.	8 weeks	No
Secondary	8-atypical items on the HAM-D-29	8-atypical items on the HAM-D-29 from baseline to end of treatment.	8 weeks	No
Secondary	Tolerability	Tolerability evaluations will be determined by TEAEs(treatment-emergent adverse events) and vital signs recording.	8 weeks	Yes
Secondary	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	8 weeks	No
Secondary	SDS(Zung Self-Rating Depression Scale)	Change of SDS from baseline to end of treatment.	8 weeks	No
Secondary	C-SSRS(The Columbia-Suicide Severity Rating Scale, changes in behaviours and ideation)	Change of C-SSRS from baseline to end of treatment.	8 weeks	No
Secondary	ESQ(Epworth Sleepiness Questionnaire)	Change of ESQ from baseline to end of treatment.	8 weeks	No
Secondary	Response	Response will be defined as 50% or greater reduction in HAM-D-29 scores from baseline to end of treatment.	8 weeks	No
Secondary	Remission	Remission will be defined as a HAM-D-29 score of = 7.	8 weeks	No