Major Depressive DisorderPhase 4NCT01997580
Electrophysiologic Parameters and Biomarkers Predicting Treatment Response in Patients With Major Depressive Disorder
A Phase 4 study testing escitalopram in people with Major Depressive Disorder, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
To explore electrophysiologic parameters and biomarkers predicting treatment response of patients with major depressive disorder To explore electrophysiologic parameters and biomarkers predicting suicide risk of patients with major depressive disorder Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- escitalopram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2013to Dec 2018
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- DSM-IV-TR major depressive disorder
- aged between 20 and 80
- durg-naive or drug-free
Who cannot join
- DSM-IV-TR substance-related disorders (except nicotine)
- significant medical or neurological conditions
- mental retardation or organic brain damage
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
Jae Seung Chang, MD, PhD, 82-31-787-7437, cjs0107@gmail.com
Meerae Lim, MD
About this study
Official title: Phase 4 Study of Escitalopram Treatment and Biomarkers in Major Depressive Disorder
To explore electrophysiologic parameters and biomarkers predicting treatment response of patients with major depressive disorder To explore electrophysiologic parameters and biomarkers predicting suicide risk of patients with major depressive disorder
Read the detailed description
Case-control study Repeated measures design
- Conditions
- Major Depressive Disorder
- Being tested
- escitalopram
- Keywords
- depression, treatment, electrophysiology, biomarker
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
escitalopramDrug
Also called lexapro
SSRI antidepressant
| Study group | Role | What they receive |
|---|---|---|
| Escitalopram | Experimental | depressed patients receiving escitalopram treatment Receives: Drug: escitalopram |
| Control | No intervention | healthy controls matched for age, gender, and BMI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in baseline frequency of maximum of cross-spectrum during 6 weeks (Hz)
the link between the normalized high frequency component of heart rate variability (HRV-HFnu) representing cardiac vagal modulation and frontal alpha power related to resting state
Measured: 0, 3, 7, 14, and 42 days
Secondary outcomes (3)
Change in cardiorespiratory coupling during 6 weeks
change in value of cross-sample entropy measured by combining sample entropies of heart rate and respiration
Measured: 0, 3, 7, 14, and 42 days
Change in HF during 6 weeks
change in high frequency component of heart rate variability
Measured: 0, 3, 7, 14, and 42 days
Change in persistent homology during 6 weeks
change in disconnection pattern of EEG channel activities measured by Euclidean distance during 6 weeks
Measured: 0, 3, 7, 14, and 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2016 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea
- Responsible party
- Principal investigator, Jae Seung Chang, Seoul National University Bundang Hospital
- Investigators
- Jae Seung Chang, MD, PhD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01997580
- Sponsor's protocol ID
- A121987
- Status last verified
- Nov 2013
- First submitted
- 19 Nov 2013
- Last updated
- 28 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chang JS, Yoo CS, Yi SH, Her JY, Choi HM, Ha TH, Park T, Ha K. An integrative assessment of the psychophysiologic alterations in young women with recurrent major depressive disorder. Psychosom Med. 2012 Jun;74(5):495-500. doi: 10.1097/PSY.0b013e31824d0da0. Epub 2012 Mar 9.
PubMed 22408133
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of Escitalopram Treatment and Biomarkers in Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT01997580
- Acronym / sponsor ID
- A121987
- Conditions
- Major Depressive Disorder
- Keywords
- depression, treatment, electrophysiology, biomarker
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea
- Study start
- Jul 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 28 Nov 2013 (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.
To explore electrophysiologic parameters and biomarkers predicting treatment response of patients with major depressive disorder To explore electrophysiologic parameters and biomarkers predicting suicide risk of patients with major depressive disorder
Detailed description
Case-control study Repeated measures design
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Escitalopram | Experimental | Drug: escitalopramdepressed patients receiving escitalopram treatment |
| Control | No intervention | –healthy controls matched for age, gender, and BMI |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- DSM-IV-TR major depressive disorder
- aged between 20 and 80
- durg-naive or drug-free
Key exclusion criteria (3 listed)
- DSM-IV-TR substance-related disorders (except nicotine)
- significant medical or neurological conditions
- mental retardation or organic brain damage
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: lexaproSSRI antidepressant | Drug | Escitalopram |
Primary outcome
Change in baseline frequency of maximum of cross-spectrum during 6 weeks (Hz)
Time frame: 0, 3, 7, 14, and 42 days
the link between the normalized high frequency component of heart rate variability (HRV-HFnu) representing cardiac vagal modulation and frontal alpha power related to resting state
3 secondary outcomes
Change in cardiorespiratory coupling during 6 weeks
Time frame: 0, 3, 7, 14, and 42 days
Change in HF during 6 weeks
Time frame: 0, 3, 7, 14, and 42 days
Change in persistent homology during 6 weeks
Time frame: 0, 3, 7, 14, and 42 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2013.
- Background: PubMed 22408133Chang JS, Yoo CS, Yi SH, Her JY, Choi HM, Ha TH, Park T, Ha K. An integrative assessment of the psychophysiologic alterations in young women with recurrent major depressive disorder. Psychosom Med. 2012 Jun;74(5):495-500. doi: 10.1097/PSY.0b013e31824d0da0. Epub 2012 Mar 9.
- health information about depressionLink provided by the sponsor.
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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.
Jae Seung Chang, MD, PhD principal investigator
Seoul National University Bundang 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 Bundang 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 28 Nov 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jae Seung Chang, MD, PhD (82-31-787-7437, cjs0107@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in baseline frequency of maximum of cross-spectrum during 6 weeks (Hz) (time frame: 0, 3, 7, 14, and 42 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01997580, which also lists 1 linked publication.
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 28 Nov 2013.