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

Chi-Un Pae

Status and phase

Completed

Phase 4

Conditions

Depressive Disorder, Major

Treatments

Drug: Bupropion extended release

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01477931

114003

Details and patient eligibility

About

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 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.

Enrollment

50 patients

Sex

All

Ages

20+ years old

Volunteers

No 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