Interventional Study of Wellbutrin XL in Major Depressive Disorder With Atypical Features (WellbutrinXL)
This study has been completed.
Sponsor:
Chi-Un Pae
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Chi-Un Pae, The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT01477931
First received: November 16, 2011
Last updated: November 22, 2011
Last verified: November 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Depressive Disorder, Major |
Drug: Bupropion extended release |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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. |
Resource links provided by NLM:
Further study details as provided by The Catholic University of Korea:
Primary Outcome Measures:
- HAM-D-29 scores(Hamilton Depression Rating Scale 29) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Changes in HAM-D-29 scores from baseline to the end of treatment.
Secondary Outcome Measures:
- 8-atypical items on the HAM-D-29 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]8-atypical items on the HAM-D-29 from baseline to end of treatment.
- Tolerability [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]Tolerability evaluations will be determined by TEAEs(treatment-emergent adverse events) and vital signs recording.
- CGI-I score(Clinical Global Impression Improvement score) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]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) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Change of SDS from baseline to end of treatment.
- C-SSRS(The Columbia-Suicide Severity Rating Scale, changes in behaviours and ideation) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Change of C-SSRS from baseline to end of treatment.
- ESQ(Epworth Sleepiness Questionnaire) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Change of ESQ from baseline to end of treatment.
- Response [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Response will be defined as 50% or greater reduction in HAM-D-29 scores from baseline to end of treatment.
- Remission [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Remission will be defined as a HAM-D-29 score of ≤ 7.
| Enrollment: | 50 |
| Study Start Date: | November 2010 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Wellbutrin XL |
Drug: Bupropion extended release
300mg once a daily, PO, 8weeks
Other Name: Wellbutrin XL
|
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| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01477931
Locations
| Korea, Republic of | |
| Korea University Ansan Hospital | |
| Ansan, Gyeonggi-Do, Korea, Republic of, 425-707 | |
| Bucheon St.Mary's Hospital | |
| Bucheon, Gyeonggi-do, Korea, Republic of, 150-713 | |
| The Catholic University of Korea, St.Vincent Hospital | |
| Suwon, Gyeonggi-do, Korea, Republic of, 442-723 | |
| The Catholic University of Korea, Uijeongbu St. Mary'S Hospital | |
| Uijeongbu, Gyeonggi-do, Korea, Republic of, 480-717 | |
| dongguk university MEDICAL CENTER | |
| Kyungju, Kyoung-Book, Korea, Republic of, 780-350 | |
| Kyung Hee University Hospital | |
| Seoul, Korea, Republic of, 130-702 | |
Sponsors and Collaborators
Chi-Un Pae
GlaxoSmithKline
Investigators
| Principal Investigator: | Chi-Un Pae, MD | Department of Psychiatry, Bucheon St.Mary's Hospital |
More Information
No publications provided
| Responsible Party: | Chi-Un Pae, Chi-Un Pae MD, phD, Department of Psychiatry, The Catholic University of Korea |
| ClinicalTrials.gov Identifier: | NCT01477931 History of Changes |
| Other Study ID Numbers: | 114003 |
| Study First Received: | November 16, 2011 |
| Last Updated: | November 22, 2011 |
| Health Authority: | Korea: Institutional Review Board |
Keywords provided by The Catholic University of Korea:
|
Bupropion hydrochloride extended release Wellbutrin XL Major Depressive Disorder with Atypical Features |
Additional relevant MeSH terms:
|
Depressive Disorder Depression Depressive Disorder, Major Mood Disorders Mental Disorders Behavioral Symptoms Bupropion Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs |
Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013