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

NCT01477931 | Completed Phase 4

• 1 other identifier: 114003
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 6

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.

Conditions

Depressive Disorder, Major

Keywords

Bupropion hydrochloride extended release; Wellbutrin XL; Major Depressive Disorder with Atypical Features

Outcome Measures

Primary Outcomes (1)

• HAM-D-29 scores(Hamilton Depression Rating Scale 29)

  Changes in HAM-D-29 scores from baseline to the end of treatment.

  8 weeks

Secondary Outcomes (8)

• 8-atypical items on the HAM-D-29

  8 weeks

• Tolerability

  8 weeks

• CGI-I score(Clinical Global Impression Improvement score)

  8 weeks

• SDS(Zung Self-Rating Depression Scale)

  8 weeks

• C-SSRS(The Columbia-Suicide Severity Rating Scale, changes in behaviours and ideation)

  8 weeks

Study Arms (1)

Wellbutrin XL

EXPERIMENTAL

Drug: Bupropion extended release

Interventions

Bupropion extended release DRUG

300mg once a daily, PO, 8weeks

Also known as: Wellbutrin XL

Wellbutrin XL

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chi-Un Pae: lead
• GlaxoSmithKline: collaborator

Study Sites (6)

Korea University Ansan Hospital

Ansan, Gyeonggi-do, 425-707, South Korea

Location

Bucheon St.Mary's Hospital

Bucheon-si, Gyeonggi-do, 150-713, South Korea

Location

The Catholic University of Korea, St.Vincent Hospital

Suwon, Gyeonggi-do, 442-723, South Korea

Location

The Catholic University of Korea, Uijeongbu St. Mary'S Hospital

Uijeongbu-si, Gyeonggi-do, 480-717, South Korea

Location

dongguk university MEDICAL CENTER

Kyungju, Kyoung-Book, 780-350, South Korea

Location

Kyung Hee University Hospital

Seoul, Seoul, 130-702, South Korea

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Bupropion

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals

Study Officials

• Chi-Un Pae, MD

  Department of Psychiatry, Bucheon St.Mary's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chi-Un Pae MD, phD, Department of Psychiatry

Study Record Dates

• First Submitted: November 16, 2011
• First Posted: November 23, 2011
• Study Start: November 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: September 1, 2011
• Last Updated: November 23, 2011

Record last verified: 2011-11

Locations

KR (6)