Depressive Disorder, MajorPhase 4WellbutrinXLNCT01477931
Interventional Study of Wellbutrin XL in Major Depressive Disorder With Atypical Features
A Phase 4 study testing Bupropion extended release in people with Depressive Disorder, Major, run by Chi-Un Pae at 6 sites in South Korea.
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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- Bupropion extended release
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 6 sitesSouth Korea
- Study dates
- Nov 2010to Sep 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 15Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites
Korea University Ansan Hospital
Ansan, Gyeonggi-do, 425-707
Bucheon St.Mary's Hospital
Bucheon-si, Gyeonggi-do, 150-713
dongguk university MEDICAL CENTER
Kyungju, Kyoung-Book, 780-350
Kyung Hee University Hospital
Seoul, Seoul, 130-702
The Catholic University of Korea, St.Vincent Hospital
Suwon, Gyeonggi-do, 442-723
The Catholic University of Korea, Uijeongbu St. Mary'S Hospital
Uijeongbu-si, Gyeonggi-do, 480-717
About this study
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.
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.
Read the 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.
- Conditions
- Depressive Disorder, Major
- Being tested
- Bupropion extended release
- Keywords
- Bupropion hydrochloride extended release, Wellbutrin XL, Major Depressive Disorder with Atypical Features
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupropion extended releaseDrug
Also called Wellbutrin XL
300mg once a daily, PO, 8weeks
| Study group | Role | What they receive |
|---|---|---|
| Wellbutrin XL | Experimental | Not described Receives: Drug: Bupropion extended release |
What is being measured
The primary outcome is the main question the study is designed to answer.
HAM-D-29 scores(Hamilton Depression Rating Scale 29)
Changes in HAM-D-29 scores from baseline to the end of treatment.
Measured: 8 weeks
Secondary outcomes (8)
8-atypical items on the HAM-D-29
8-atypical items on the HAM-D-29 from baseline to end of treatment.
Measured: 8 weeks
Tolerability
Tolerability evaluations will be determined by TEAEs(treatment-emergent adverse events) and vital signs recording.
Measured: 8 weeks
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
Measured: 8 weeks
SDS(Zung Self-Rating Depression Scale)
Change of SDS from baseline to end of treatment.
Measured: 8 weeks
C-SSRS(The Columbia-Suicide Severity Rating Scale, changes in behaviours and ideation)
Change of C-SSRS from baseline to end of treatment.
Measured: 8 weeks
ESQ(Epworth Sleepiness Questionnaire)
Change of ESQ from baseline to end of treatment.
Measured: 8 weeks
Response
Response will be defined as 50% or greater reduction in HAM-D-29 scores from baseline to end of treatment.
Measured: 8 weeks
Remission
Remission will be defined as a HAM-D-29 score of ≤ 7.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2011 (estimated)
- Study startNov 2010
- Primary completionJul 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chi-Un Pae
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor-investigator, Chi-Un Pae, The Catholic University of Korea
- Investigators
- Chi-Un Pae, MD, Principal investigator, Department of Psychiatry, Bucheon St.Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01477931
- Sponsor's protocol ID
- 114003
- Acronym
- WellbutrinXL
- Status last verified
- Nov 2011
- First submitted
- 16 Nov 2011
- Last updated
- 23 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01477931
- Acronym / sponsor ID
- WellbutrinXL / 114003
- Conditions
- Depressive Disorder, Major
- Keywords
- Bupropion hydrochloride extended release, Wellbutrin XL, Major Depressive Disorder with Atypical Features
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Chi-Un PaeUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Nov 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 23 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wellbutrin XL | Experimental | Drug: Bupropion extended release |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupropion extended releaseAlso: Wellbutrin XL300mg once a daily, PO, 8weeks | Drug | Wellbutrin XL |
Primary outcome
HAM-D-29 scores(Hamilton Depression Rating Scale 29)
Time frame: 8 weeks
Changes in HAM-D-29 scores from baseline to the end of treatment.
8 secondary outcomes
8-atypical items on the HAM-D-29
Time frame: 8 weeks
Tolerability
Time frame: 8 weeks
CGI-I score(Clinical Global Impression Improvement score)
Time frame: 8 weeks
SDS(Zung Self-Rating Depression Scale)
Time frame: 8 weeks
C-SSRS(The Columbia-Suicide Severity Rating Scale, changes in behaviours and ideation)
Time frame: 8 weeks
ESQ(Epworth Sleepiness Questionnaire)
Time frame: 8 weeks
Response
Time frame: 8 weeks
Remission
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chi-Un Pae, MD principal investigator
Department of Psychiatry, Bucheon St.Mary's Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupropion extended release in people with Depressive Disorder, Major, run by Chi-Un Pae at 6 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HAM-D-29 scores(Hamilton Depression Rating Scale 29) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2011.