Major Depressive DisorderPhase 4NCT00926835
Effect of Antidepressants on the Treatment for Korean Major Depressive Disorder Patients
A Phase 4 study testing paroxetine, Escitalopram and Venlafaxine XR in people with Major Depressive Disorder, run by Ministry of Health & Welfare, Korea at 1 site in South Korea.
Trial summary
The primary purpose of this study is to investigate the effectiveness of antidepressants on the treatments for non-psychotic major depressive disorder (MDD) in Korea. The study divides MDD patients into 3 level groups according to their past histories to treatments and compares the effectiveness of various treatment… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- paroxetine, Escitalopram and Venlafaxine XR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 692 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2009to Jul 2015
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of non-psychotic Major depressive disorder
- HAMD-17 score 14 or greater
- Age of 18 or greater and 65 or less
Who cannot join
- patients with current or past history of diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, or psychotic disorder NOS
- patients with current psychotic features, eating disorders or obsessive-compulsive disorder
- patients with neurological disorder
- patients with medical condition that could interfere with everyday life activities
- pregnant or lactating women,
- patients with current other DSM-IV TR Axis I diagnosis other than MDD which needs inpatient care
Show all 9Show fewer
- patients who treated with ECT for current depressive episode
- insufficient information of past treatment for current depressive episode
- patients who posed a serious suicidal risk.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Clinical research center for depression
Seoul, Seoul, 150713
About this study
Official title: A Study to Investigate the Effect of Antidepressants on the Treatment for Korean Major Depressive Disorder (MDD) Patients
The primary purpose of this study is to investigate the effectiveness of antidepressants on the treatments for non-psychotic major depressive disorder (MDD) in Korea. The study divides MDD patients into 3 level groups according to their past histories to treatments and compares the effectiveness of various treatment regimens at each level.
The treatment level groups are: 1) patients who have never been treated with appropriate medications for their current depressive symptoms before, 2) who received an appropriate SSRI (Selective Serotonin Reuptake Inhibitor) once but did not respond to it, 3) who received two types of SSRI antidepressant treatments without much effects in reducing their depressive symptoms.
The first level group will be treated with a single SSRI antidepressant treatment. The second and third level groups, who received SSRI treatment before, will be treated with alternative SSRI antidepressants (switching), combined multiple SSRI treatments (antidepressant combination), or SSRI treatments combined with mood stabilizer or anti-psychotics (augmentation). This study does not use placebos. Patients will visit 5 times for 6 weeks at each level for treatments. Patients will be evaluated for the severity of depressive symptoms, functional level, and side effects at each visit. Afterwards, the investigations will combine to monitor the patients depressive symptoms in every 3 months for the next 24 months. 18 nationwide university hospitals will participate in this study. This multi-site, prospective, and naturalistic study for patients with depression in Korea is a main project of 'Clinical Research Center for Depression' funded by the Ministry for Health, Welfare, and Family Affairs (MIHWAF) in Korea for a highly-qualified research achievement.
Read the detailed description
Patients will be classified into 3 levels by their past therapeutic histories:
Level 1: Patients who do not receive an appropriate treatment for their current major depressive episode.
Level 2: Patients who never showed a satisfactory response to an adequate dosage of Paroxetine during a sufficient period of their current major depressive episode.
Level 3: Patients without a satisfactory response to two or more antidepressants including one of Paroxetine or Escitalopram for a sufficient period.
A satisfactory response means baseline HAM-D17 score was reduced over 50% or HAM-D17 score 10 or below and a sufficient period means 6 weeks.
Patients will be randomly assigned to the following treatment groups. Patients in level 1 will be randomly assigned to treatment groups among Paroxetine monotherapy, Escitalopram monotherapy, or Venlafaxine monotherapy.
Patients in level 2 will be enrolled who were medicated Paroxetine monotherapy in level 1 and assigned to one of the following 4 groups; Escitalopram monotherapy, Venlafaxine monotherapy, Paroxetine combined with Venlafaxine, or Paroxetine augmented with Lithium.
Patients in level 3 will be randomly assigned to one of the following 4 groups: 1) Either Paroxetine combined with Lamotrigine or Paroxetine combined with Bupropion if they resist two antidepressants including Paroxetine. 2) Either Escitalopram combined with Mirtazapine or Escitalopram combined with Aripiprazole if they resist two antidepressants including Escitalopram. 3) Patients who does not respond to both Paroxetine and Escitalopram will be randomly assigned to either 1) or 2).
- Conditions
- Major Depressive Disorder
- Being tested
- paroxetine, Escitalopram, Venlafaxine XR, Paroxetine+Bupropion, Paroxetine+Lamotrigine
- 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.
paroxetineDrug
Also called Seroxat
6 weeks, 20-50mg/day
EscitalopramDrug
Also called lexapro
10-20mg/day for 6 weeks
Venlafaxine XRDrug
Also called Efexor XR
Venlafaxine 75-225mg/day for 6 weeks
Paroxetine+BupropionDrug
Also called Seroxat, wellbutrin
paroxetine 20-50mg/day + bupropion 150-400mg/day for 6 weeks
Paroxetine+LamotrigineDrug
Also called seroxat, lamictal
Paroxetine 20-50mg/day + lamotrigine 100-400mg/day for 6 weeks
Paroxetine+LithiumDrug
Also called seroxat, lithan
Paroxetine 20-50mg/day + lithium 0.5-1.2 mEq/L
Escitalopram+MirtazapineDrug
Also called lexapro, remeron
escitalopram 10-20mg/day + mirtazapine 15-45mg/day for 6 weeks
Escitalopram+AripiprazoleDrug
Also called lexapro, abilify
escitalopram 10-20mg/day + aripiprazole 5-15mg/day for 6 weeks
Paroxetine + Venlafaxine XRDrug
Also called seroxat, efexor XR
Paroxetine 20-50mg/day + Venlafaxine 75-225mg/day for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Paroxetine | Experimental | Paroxetine monotherapy Receives: Drug: paroxetine |
| Escitalopram | Active comparator | Escitalopram monotherapy Receives: Drug: Escitalopram |
| Venlafaxine | Active comparator | Venlafaxine monotherapy Receives: Drug: Venlafaxine XR |
| Paroxetine+Bupropion | Active comparator | Not described Receives: Drug: Paroxetine+Bupropion |
| Paroxetine+Lamotrigine | Active comparator | Not described Receives: Drug: Paroxetine+Lamotrigine |
| Paroxetine+Lithium | Active comparator | Not described Receives: Drug: Paroxetine+Lithium |
| escitalopram+mirtazapine | Active comparator | Not described Receives: Drug: Escitalopram+Mirtazapine |
| Escitalopram+Aripiprazole | Active comparator | Not described Receives: Drug: Escitalopram+Aripiprazole |
| Paroxetine + Venlafaxine | Active comparator | Not described Receives: Drug: Paroxetine + Venlafaxine XR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2009 (estimated)
- Study startMay 2009
- Primary completionMay 2015
- Study completionJul 2015
Why it stopped: due to patient recruitment difficulties
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
- Outcomes assessor
- Enrolment
- 692 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Health & Welfare, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jun Tae-Youn, The Catholic University of Korea
- Investigators
- Tae-Youn Jun, MD, PhD, Study chair, Clinical research center for depression
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00926835
- Sponsor's protocol ID
- MIHWAF-CRCD-K-01
- Status last verified
- Sep 2015
- First submitted
- 23 Jun 2009
- Last updated
- 2 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Investigate the Effect of Antidepressants on the Treatment for Korean Major Depressive Disorder (MDD) Patients
- ClinicalTrials.gov ID
- NCT00926835
- Acronym / sponsor ID
- MIHWAF-CRCD-K-01
- Conditions
- Major Depressive Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to patient recruitment difficulties
- Enrolment
- 692 participants (actual)
- Lead sponsor
- Ministry of Health & Welfare, KoreaOther government
- Study start
- May 2009
- Primary completion
- May 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 24 Jun 2009 (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 primary purpose of this study is to investigate the effectiveness of antidepressants on the treatments for non-psychotic major depressive disorder (MDD) in Korea. The study divides MDD patients into 3 level groups according to their past histories to treatments and compares the effectiveness of various treatment regimens at each level.
The treatment level groups are: 1) patients who have never been treated with appropriate medications for their current depressive symptoms before, 2) who received an appropriate SSRI (Selective Serotonin Reuptake Inhibitor) once but did not respond to it, 3) who received two types of SSRI antidepressant treatments without much effects in reducing their depressive symptoms.
The first level group will be treated with a single SSRI antidepressant treatment. The second and third level groups, who received SSRI treatment before, will be treated with alternative SSRI antidepressants (switching), combined multiple SSRI treatments (antidepressant combination), or SSRI treatments combined with mood stabilizer or anti-psychotics (augmentation). This study does not use placebos. Patients will visit 5 times for 6 weeks at each level for treatments. Patients will be evaluated for the severity of depressive symptoms, functional level, and side effects at each visit. Afterwards, the investigations will combine to monitor the patients depressive symptoms in every 3 months for the next 24 months. 18 nationwide university hospitals will participate in this study. This multi-site, prospective, and naturalistic study for patients with depression in Korea is a main project of 'Clinical Research Center for Depression' funded by the Ministry for Health, Welfare, and Family Affairs (MIHWAF) in Korea for a highly-qualified research achievement.
Detailed description
Patients will be classified into 3 levels by their past therapeutic histories:
Level 1: Patients who do not receive an appropriate treatment for their current major depressive episode.
Level 2: Patients who never showed a satisfactory response to an adequate dosage of Paroxetine during a sufficient period of their current major depressive episode.
Level 3: Patients without a satisfactory response to two or more antidepressants including one of Paroxetine or Escitalopram for a sufficient period.
A satisfactory response means baseline HAM-D17 score was reduced over 50% or HAM-D17 score 10 or below and a sufficient period means 6 weeks.
Patients will be randomly assigned to the following treatment groups. Patients in level 1 will be randomly assigned to treatment groups among Paroxetine monotherapy, Escitalopram monotherapy, or Venlafaxine monotherapy.
Patients in level 2 will be enrolled who were medicated Paroxetine monotherapy in level 1 and assigned to one of the following 4 groups; Escitalopram monotherapy, Venlafaxine monotherapy, Paroxetine combined with Venlafaxine, or Paroxetine augmented with Lithium.
Patients in level 3 will be randomly assigned to one of the following 4 groups: 1) Either Paroxetine combined with Lamotrigine or Paroxetine combined with Bupropion if they resist two antidepressants including Paroxetine. 2) Either Escitalopram combined with Mirtazapine or Escitalopram combined with Aripiprazole if they resist two antidepressants including Escitalopram. 3) Patients who does not respond to both Paroxetine and Escitalopram will be randomly assigned to either 1) or 2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Paroxetine | Experimental | Drug: paroxetineParoxetine monotherapy |
| Escitalopram | Active comparator | Drug: EscitalopramEscitalopram monotherapy |
| Venlafaxine | Active comparator | Drug: Venlafaxine XRVenlafaxine monotherapy |
| Paroxetine+Bupropion | Active comparator | Drug: Paroxetine+Bupropion |
| Paroxetine+Lamotrigine | Active comparator | Drug: Paroxetine+Lamotrigine |
| Paroxetine+Lithium | Active comparator | Drug: Paroxetine+Lithium |
| escitalopram+mirtazapine | Active comparator | Drug: Escitalopram+Mirtazapine |
| Escitalopram+Aripiprazole | Active comparator | Drug: Escitalopram+Aripiprazole |
| Paroxetine + Venlafaxine | Active comparator | Drug: Paroxetine + Venlafaxine XR |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of non-psychotic Major depressive disorder
- HAMD-17 score 14 or greater
- Age of 18 or greater and 65 or less
Key exclusion criteria (9 listed)
- patients with current or past history of diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, or psychotic disorder NOS
- patients with current psychotic features, eating disorders or obsessive-compulsive disorder
- patients with neurological disorder
- patients with medical condition that could interfere with everyday life activities
- pregnant or lactating women,
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 |
|---|---|---|
| paroxetineAlso: Seroxat6 weeks, 20-50mg/day | Drug | Paroxetine |
| EscitalopramAlso: lexapro10-20mg/day for 6 weeks | Drug | Escitalopram |
| Venlafaxine XRAlso: Efexor XRVenlafaxine 75-225mg/day for 6 weeks | Drug | Venlafaxine |
| Paroxetine+BupropionAlso: Seroxat, wellbutrinparoxetine 20-50mg/day + bupropion 150-400mg/day for 6 weeks | Drug | Paroxetine+Bupropion |
| Paroxetine+LamotrigineAlso: seroxat, lamictalParoxetine 20-50mg/day + lamotrigine 100-400mg/day for 6 weeks | Drug | Paroxetine+Lamotrigine |
| Paroxetine+LithiumAlso: seroxat, lithanParoxetine 20-50mg/day + lithium 0.5-1.2 mEq/L | Drug | Paroxetine+Lithium |
| Escitalopram+MirtazapineAlso: lexapro, remeronescitalopram 10-20mg/day + mirtazapine 15-45mg/day for 6 weeks | Drug | escitalopram+mirtazapine |
| Escitalopram+AripiprazoleAlso: lexapro, abilifyescitalopram 10-20mg/day + aripiprazole 5-15mg/day for 6 weeks | Drug | Escitalopram+Aripiprazole |
| Paroxetine + Venlafaxine XRAlso: seroxat, efexor XRParoxetine 20-50mg/day + Venlafaxine 75-225mg/day for 6 weeks | Drug | Paroxetine + Venlafaxine |
Primary outcome
Hamilton Depression Rating Scale
Time frame: 6 week
Results and safety
The study was stopped early (reason given: due to patient recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2015.
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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.
Tae-Youn Jun, MD, PhD study chair
Clinical research center for depression
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 paroxetine, Escitalopram and Venlafaxine XR in people with Major Depressive Disorder, run by Ministry of Health & Welfare, Korea 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: stopped early, as of the sponsor's last update on 2 Sep 2015. 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 was stopped early (reason given: due to patient recruitment difficulties). Results are not available in the source record.
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?
Hamilton Depression Rating Scale (time frame: 6 week). 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 2 Sep 2015.