Clinical trial NCT01477931: Interventional Study of Wellbutrin XL in Major Depressive Disorder With Atypical Features
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Depressive Disorder, Major
Keywords: Bupropion hydrochloride extended release
Wellbutrin XL
Major Depressive Disorder with Atypical Features
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2011-11-23
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: HAM-D-29 scores(Hamilton Depression Rating Scale 29)
timeFrame: 8 weeks
Secondary outcomes:
measure: 8-atypical items on the HAM-D-29
timeFrame: 8 weeks
measure: Tolerability
timeFrame: 8 weeks
measure: CGI-I score(Clinical Global Impression Improvement score)
timeFrame: 8 weeks
measure: SDS(Zung Self-Rating Depression Scale)
timeFrame: 8 weeks
measure: C-SSRS(The Columbia-Suicide Severity Rating Scale, changes in behaviours and ideation)
timeFrame: 8 weeks
measure: ESQ(Epworth Sleepiness Questionnaire)
timeFrame: 8 weeks
measure: Response
timeFrame: 8 weeks
measure: Remission
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Ansan
country: Korea, Republic of
facility: Korea University Ansan Hospital
state: Gyeonggi-Do
city: Bucheon
country: Korea, Republic of
facility: Bucheon St.Mary's Hospital
state: Gyeonggi-do
city: Suwon
country: Korea, Republic of
facility: The Catholic University of Korea, St.Vincent Hospital
state: Gyeonggi-do
city: Uijeongbu
country: Korea, Republic of
facility: The Catholic University of Korea, Uijeongbu St. Mary'S Hospital
state: Gyeonggi-do
city: Kyungju
country: Korea, Republic of
facility: dongguk university MEDICAL CENTER
state: Kyoung-Book
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
Study officials:
affiliation: Department of Psychiatry, Bucheon St.Mary's Hospital
name: Chi-Un Pae, MD
role: PRINCIPAL_INVESTIGATOR
References: