Major Depressive DisorderPhase 4NCT01541475
Neuroimaging Study of Bupropion Treatment in Patients With Major Depressive Disorder
A Phase 4 study testing Bupropion, Escitalopram and Escitalopram in people with Major Depressive Disorder, run by Ewha Womans University at 1 site in South Korea.
Trial summary
The current study is being conducted in patients with major depression. The study aims to 1) investigate the combined effects of selective serotonin reuptake inhibitor (SSRI) and bupropion compared to SSRI alone on the improvements of depressive symptoms, fatigue, hypersomnia, and neurocognitive functions, 2) observe… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Bupropion, Escitalopram and Escitalopram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2009to Jan 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged between 20 and 65
- Diagnosis of major depressive disorder (MDD) as assessed by the Structured Clinical Interview for DSM-IV (SCID-IV)
- Individuals who provided written consent for participation.
Who cannot join
- Presence of any major physical or neurological illness (e.g., head trauma, epilepsy, seizure, stroke, cerebral tumor, multiple sclerosis, cerebrovascular disease, narrow-angle glaucoma, drug hypersensitivity, etc.)
- Diagnosis of any Axis I disorder other than MDD or presence of symptoms requiring hospitalization
- Intelligence quotient (IQ) below 80
- Contraindications to magnetic resonance imaging (e.g., pacemaker implantation, claustrophobia, etc.)
- Unstable medical illness or other abnormalities observed at the screening or laboratory tests
- Women who are pregnant, breastfeeding, or planning pregnancy
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- Allergy or tolerance to the clinical trial medication
- Presence of any physical illness that contraindicates the clinical trial medication (e.g., epilepsy, history of uncontrollable narrow-angle glaucoma)
- Use of psychoactive medications that may affect brain imaging findings
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital, Biomedical Research Institute
Seoul, Seoul, 110-744
About this study
The current study is being conducted in patients with major depression. The study aims to 1) investigate the combined effects of selective serotonin reuptake inhibitor (SSRI) and bupropion compared to SSRI alone on the improvements of depressive symptoms, fatigue, hypersomnia, and neurocognitive functions, 2) observe structural/functional/chemical changes using magnetic resonance imaging (MRI), 3) and examine a relationship between the improvements of depressive symptoms, fatigue, and hypersomnia and the neural changes.
- Conditions
- Major Depressive Disorder
- Being tested
- Bupropion, Escitalopram, Escitalopram
- 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, EscitalopramDrug
Week 0-1: Escitalopram 10mg, Bupropion 150mg Week 2-3: Escitalopram 10mg, Bupropion 300mg Week 4-8: Escitalopram 20mg, Bupropion 300mg
EscitalopramDrug
Week 0-3: Escitalopram 10mg Week 4-8: Escitalopram 20mg
| Study group | Role | What they receive |
|---|---|---|
| Escitalopram + Bupropion | Experimental | Not described Receives: Drug: Bupropion, Escitalopram |
| Escitalopram | Active comparator | Not described Receives: Drug: Escitalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Depressive Symptom Scores at 8 Weeks
Measured: Baseline and at 8 Weeks
Change from Baseline in Depressive Symptom Scores at 4 Weeks
Measured: Baseline and at 4 Weeks
Change from Baseline in Depressive Symptom Scores at 1 Week
Measured: Baseline and at 1 Week
Secondary outcomes (6)
Number of Participants with Adverse Events
Measured: 1 Week
Change from Baseline in Neurocognitive Function as Expressed as Z Scores Transformed Using the Control Group Mean and Distribution Values at 8 Weeks
Measured: Baseline and 8 Weeks
Changes from Baseline in Brain Structure and Function, Analyzed Using the Computational Approach
Measured: Baseline and 8 Weeks
Number of Participants with Adverse Events
Measured: 4 Weeks
Number of Participants with Adverse Events
Measured: 8 Weeks
Changes in Fatigue Severity Scale scores
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2012 (estimated)
- Study startMar 2009
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ewha Womans University
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, In Kyoon Lyoo, Ewha Womans University
- Investigators
- In Kyoon Lyoo, MD, PhD, MMS, Principal investigator, Ehwa W. univ hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01541475
- Sponsor's protocol ID
- 112063
- Other IDs
- GSK IIT
- Status last verified
- Apr 2014
- First submitted
- 17 Feb 2012
- Last updated
- 10 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroimaging Study of Bupropion Treatment in Patients With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT01541475
- Acronym / sponsor ID
- 112063
- Conditions
- Major Depressive Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ewha Womans UniversityUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Mar 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 1 Mar 2012 (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 current study is being conducted in patients with major depression. The study aims to 1) investigate the combined effects of selective serotonin reuptake inhibitor (SSRI) and bupropion compared to SSRI alone on the improvements of depressive symptoms, fatigue, hypersomnia, and neurocognitive functions, 2) observe structural/functional/chemical changes using magnetic resonance imaging (MRI), 3) and examine a relationship between the improvements of depressive symptoms, fatigue, and hypersomnia and the neural changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Escitalopram + Bupropion | Experimental | Drug: Bupropion, Escitalopram |
| Escitalopram | Active comparator | Drug: Escitalopram |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women aged between 20 and 65
- Diagnosis of major depressive disorder (MDD) as assessed by the Structured Clinical Interview for DSM-IV (SCID-IV)
- Individuals who provided written consent for participation.
Key exclusion criteria (9 listed)
- Presence of any major physical or neurological illness (e.g., head trauma, epilepsy, seizure, stroke, cerebral tumor, multiple sclerosis, cerebrovascular disease, narrow-angle glaucoma, drug hypersensitivity, etc.)
- Diagnosis of any Axis I disorder other than MDD or presence of symptoms requiring hospitalization
- Intelligence quotient (IQ) below 80
- Contraindications to magnetic resonance imaging (e.g., pacemaker implantation, claustrophobia, etc.)
- Unstable medical illness or other abnormalities observed at the screening or laboratory tests
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, EscitalopramWeek 0-1: Escitalopram 10mg, Bupropion 150mg Week 2-3: Escitalopram 10mg, Bupropion 300mg Week 4-8: Escitalopram 20mg, Bupropion 300mg | Drug | Escitalopram + Bupropion |
| EscitalopramWeek 0-3: Escitalopram 10mg Week 4-8: Escitalopram 20mg | Drug | Escitalopram |
Primary outcome
Change from Baseline in Depressive Symptom Scores at 8 Weeks
Time frame: Baseline and at 8 Weeks
Change from Baseline in Depressive Symptom Scores at 4 Weeks
Time frame: Baseline and at 4 Weeks
Change from Baseline in Depressive Symptom Scores at 1 Week
Time frame: Baseline and at 1 Week
6 secondary outcomes
Number of Participants with Adverse Events
Time frame: 1 Week
Change from Baseline in Neurocognitive Function as Expressed as Z Scores Transformed Using the Control Group Mean and Distribution Values at 8 Weeks
Time frame: Baseline and 8 Weeks
Changes from Baseline in Brain Structure and Function, Analyzed Using the Computational Approach
Time frame: Baseline and 8 Weeks
Number of Participants with Adverse Events
Time frame: 4 Weeks
Number of Participants with Adverse Events
Time frame: 8 Weeks
Changes in Fatigue Severity Scale scores
Time frame: Week 8
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 10 Apr 2014.
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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.
In Kyoon Lyoo, MD, PhD, MMS principal investigator
Ehwa W. univ hospital
1 site 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, Escitalopram and Escitalopram in people with Major Depressive Disorder, run by Ewha Womans University at 1 site 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 3 inclusion and 9 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 10 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Change from Baseline in Depressive Symptom Scores at 8 Weeks (time frame: Baseline and at 8 Weeks). The study lists 3 primary outcomes in all. 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 10 Apr 2014.