Major Depressive DisorderPhase 4LEADERSNCT01594866
Lexapro®'s Efficacy After Dose Escalation in Remission Study
A Phase 4 study testing escitalopram in people with Major Depressive Disorder, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is the evaluation of remission rate between escitalopram 20 mg and 30 mg in patients with major depressive disorder. 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?
- escitalopram
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2012to Dec 2016
- 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
- Age: 18 ~ 65
- Patient with major depressive disorder according to DSM-IV criteria
- Patient have signed on the informed consent, and well understood the objective and procedure of this study.
- MADRS total score ≥ 18
- Competent patient who is manage to answer the questionnaires.
- In case of female at child-bearing age, consent to use appropriate contraceptive methods(oral pill, contraceptive injection, intrauterine device, double barrier method and contraceptive patch) during entire duration of this study.
Who cannot join
- In previous depressive episodes, no efficacy although more than one antidepressant treatment
- Allergy or hypersensitivity to escitalopram
- Diagnosed to schizophrenia or bipolar disorder or schizoaffective disorder (DSM-IV)
- MADRS 10 score ≥ 5, or patient who is supposed to be impossible to participate to this study due to clinical risk of suicide or aggressive behavior based on clinician's opinion
- Pregnant or breast-feeding female patient
- Significant biochemical or hematological abnormality or abnormal finding of urinalysis, based on clinician's opinion
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- Significant severe medical condition
- Patients who take antipsychotics or mood stabilizer or other psychiatric drugs excluding benzodiazepines or beta blockers or hypnotics
- History of participating to other investigational drug trial within 1month prior to screening
- Investigator or employee at clinical trial center, personnel related to investigator or trial center on this or other study, or family of employee or investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blinded 6-week Prospective Study to Evaluate the Remission Rate According to Dose of Escitalopram (Lexapro®) in Patients With Major Depressive Disorder: a Preliminary Study
The purpose of this study is the evaluation of remission rate between escitalopram 20 mg and 30 mg in patients with major depressive disorder.
Read the detailed description
In this study, the investigators are going to examine the efficacy of escitalopram after dose escalation and evaluate remission rate. This study design is the double-blinded 6-week prospective study. It would be useful for clinicians because there were few study of high-dose antidepressant treatment in lack of remission in major depressive disorder patients. To control of bias, the investigators included patients with lack of remission after 4-week escitalopram treatment.
- Conditions
- Major Depressive Disorder
- Being tested
- escitalopram
- Keywords
- Major depressive disorder, remission, 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.
escitalopramDrug
Also called Lexapro®
escitalopram 20mg and 30mg p.o. daily, 6 weeks
escitalopramDrug
Also called Lexapro®
escitalopram 10mg p.o. for 1 week, and escitalopram 20mg p.o. for 3 weeks before randomized to placebo and experimental groups
| Study group | Role | What they receive |
|---|---|---|
| Escitalopram, 20mg, placebo | Placebo comparator | escitalopram 20mg + placebo (same taste, appearance, texture of escitalopram 10mg) Receives: Drug: escitalopram |
| Escitalopram 20mg, escitalopram 10mg | Experimental | Escitalopram 20mg + Escitalopram 10mg Receives: Drug: escitalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Åsberg Depression Rating Scale (MADRS)
Measured: 6 weeks
Secondary outcomes (8)
Hamilton Depression Rating Scale-17 items (HAM-D)
Measured: 6 weeks
Hamilton Anxiety Rating Scale (HAM-A)
Measured: 6 weeks
Clinical Global Impression-severity (CGI-S)
Measured: 6 weeks
Clinical Global Impression-Improvement (CGI-I)
Measured: 6 weeks
Beck's Depression Inventory(BDI)
Measured: 6 weeks
WHO Quality Of Life scale Abbreviated Version(WHOQOL-BREF)
Measured: 6 weeks
Clinically Useful Depression Outcome Scale (CUDOS)
Measured: 6 weeks
Short From-36 Health survey (SF-36 Health survey)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2012 (estimated)
- Study startMay 2012
- Primary completionJun 2016
- Study completionDec 2016
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.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- H. Lundbeck A/S
- Responsible party
- Principal investigator, Yong Min Ahn, Seoul National University Hospital
- Investigators
- Yong Min Ahn, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01594866
- Sponsor's protocol ID
- AYM-LEADERS
- Acronym
- LEADERS
- Status last verified
- Sep 2018
- First submitted
- 7 May 2012
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blinded 6-week Prospective Study to Evaluate the Remission Rate According to Dose of Escitalopram (Lexapro®) in Patients With Major Depressive Disorder: a Preliminary Study
- ClinicalTrials.gov ID
- NCT01594866
- Acronym / sponsor ID
- LEADERS / AYM-LEADERS
- Conditions
- Major Depressive Disorder
- Keywords
- Major depressive disorder, remission, escitalopram
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- H. Lundbeck A/S
- Study start
- May 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 9 May 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 purpose of this study is the evaluation of remission rate between escitalopram 20 mg and 30 mg in patients with major depressive disorder.
Detailed description
In this study, the investigators are going to examine the efficacy of escitalopram after dose escalation and evaluate remission rate. This study design is the double-blinded 6-week prospective study. It would be useful for clinicians because there were few study of high-dose antidepressant treatment in lack of remission in major depressive disorder patients. To control of bias, the investigators included patients with lack of remission after 4-week escitalopram treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Escitalopram, 20mg, placebo | Placebo comparator | Drug: escitalopramescitalopram 20mg + placebo (same taste, appearance, texture of escitalopram 10mg) |
| Escitalopram 20mg, escitalopram 10mg | Experimental | Drug: escitalopramEscitalopram 20mg + Escitalopram 10mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: 18 ~ 65
- Patient with major depressive disorder according to DSM-IV criteria
- Patient have signed on the informed consent, and well understood the objective and procedure of this study.
- MADRS total score ≥ 18
- Competent patient who is manage to answer the questionnaires.
Key exclusion criteria (10 listed)
- In previous depressive episodes, no efficacy although more than one antidepressant treatment
- Allergy or hypersensitivity to escitalopram
- Diagnosed to schizophrenia or bipolar disorder or schizoaffective disorder (DSM-IV)
- MADRS 10 score ≥ 5, or patient who is supposed to be impossible to participate to this study due to clinical risk of suicide or aggressive behavior based on clinician's opinion
- Pregnant or breast-feeding female patient
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 |
|---|---|---|
| escitalopramAlso: Lexapro®escitalopram 20mg and 30mg p.o. daily, 6 weeks | Drug | Escitalopram 20mg, escitalopram 10mg, Escitalopram, 20mg, placebo |
| escitalopramAlso: Lexapro®escitalopram 10mg p.o. for 1 week, and escitalopram 20mg p.o. for 3 weeks before randomized to placebo and experimental groups | Drug | Escitalopram 20mg, escitalopram 10mg, Escitalopram, 20mg, placebo |
Primary outcome
Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: 6 weeks
8 secondary outcomes
Hamilton Depression Rating Scale-17 items (HAM-D)
Time frame: 6 weeks
Hamilton Anxiety Rating Scale (HAM-A)
Time frame: 6 weeks
Clinical Global Impression-severity (CGI-S)
Time frame: 6 weeks
Clinical Global Impression-Improvement (CGI-I)
Time frame: 6 weeks
Beck's Depression Inventory(BDI)
Time frame: 6 weeks
WHO Quality Of Life scale Abbreviated Version(WHOQOL-BREF)
Time frame: 6 weeks
Clinically Useful Depression Outcome Scale (CUDOS)
Time frame: 6 weeks
Short From-36 Health survey (SF-36 Health survey)
Time frame: 6 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 7 Sep 2018.
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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.
Yong Min Ahn, MD, PhD principal investigator
Seoul National University 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 escitalopram in people with Major Depressive Disorder, run by Seoul National University Hospital 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 6 inclusion and 10 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 7 Sep 2018. 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. Some participants in this study may receive a placebo. 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?
Montgomery-Åsberg Depression Rating Scale (MADRS) (time frame: 6 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 7 Sep 2018.