Major Depressive DisorderNCT02983838
Research on Pathophysiology and Treatment in Depression Using Brain Derived Neurotrophic Factor and Amyloid Neuroimaging
An observational study of Major Depressive Disorder, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Target of the research Based on change of Brain-derived neurotrophic factor and other pro-inflammatory cytokine along with symptom improvement following treatment, the investigators are trying to find the new treatment target molecule. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2016to Dec 2017
- How long will I take part?
- 1 Month
- Phase
- Observational
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: older than 65 years free from other main psychiatric diagnosis except major depressive disorder free from neurocognitive disorder normal control: older than 65 years
Who may be able to join
- Diagnosed as major depressive disorder with MINI and DSM-5 criteria whose age is more than 65 years
- Whose score of Hamilton Depression Scale is more than 16
- Whose first depressive episode onset was later than one's age of 60
- Who is free from antidepressants for 2 weeks
Who cannot join
- Subjects with past history of Psychotic disorder or with present symptoms related to psychotic disorders
- Bipolar Spectrum Disorder
- With Neurocognitive disorder such as Parkinson's disease, Huntington's chorea, Mild Cognitive Disorder, or Dementia
- Who ever diagnosed as a Cognitive disability
- Who have serious medical condition which needs to be cared (e.g, cancer)
- Who have past history of epileptic disorder or present with epileptic disorder in treatment
Show all 10Show fewer
- Who have recent history of alcohol or other substance use disorder within 6 months and suspicious for this condition
- Who is suspicious for the clinically implicable personality disorder
- Who is suspicious for the brain injury
- Who is having trouble with uncontrolled claustrophobia, hard to go through neuroimaging
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, Irwon-dong, Gangnam-gu, 135710
Hong Jin Jeon, MD, PhD, 82-10-3198-3586, jhj001001@gmail.com
About this study
Official title: Development of Biomarker With Neuroimaging : Research on Pathophysiology and Treatment in Depression Using Brain Derived Neurotrophic Factor (BDNF) and Amyloid Neuroimaging
Target of the research Based on change of Brain-derived neurotrophic factor and other pro-inflammatory cytokine along with symptom improvement following treatment, the investigators are trying to find the new treatment target molecule. The investigators will follow up the subjective and objective cognitive dysfunction with psychiatric symptom profiles and compare the neuroimaging related to these change.
Read the detailed description
Recently the investigators reported the association between childhood trauma and refractory depression, which related to Brain Derived Neurotrophic Factor (BDNF). Even though level of peripheral BDNF is closely related to depression treatment, the investigators still have little idea on role of BDNF. In this research, the investigators are going to find the genetic variation affecting treatment response and process, figure out specific role of BDNF in depressive patient correlated with Neuroimaging. Along with BDNF, many kinds of proinflammatory cytokine showed increased amount related to depressive patient. Leptin, adiponectin, and plasma tryptohphan are also seen to be related to response of depression. Here, the investigators are trying to see specific difference on neuroimaging shown in depressive patient related to peripheral marker. The investigators will evaluate the 36 depressive patients compared to 24 normal control. For depressive patients, after excluding other bipolar spectrum disorder, psychotic disorder, other neurocognitive disorder, subjects who have organic brain lesion, tested as HAM D score above 16, will be included in this research. As a psychiatric evaluation, the investigators will do the MINI International Psychiatric Interview Plus (MINI Plus), Suicidal ideation evaluation, Hamilton Depression Inventory 17 (HAM D 17), Hamilton Anxiety Inventory (HAM A) to get the information of their clinical severity. As a neuroimaging evaluation, the investigators will do the magnetic resonance imaging (MRI) with diffusion tensor imaging and amyloid Positron Emission Tomography(PET) to see the specific deposition. For peripheral marker for inflammation and other neurotrophic factor, the investigators will do the platelet BDNF level,and other pre-inflammatory factors. The investigators will also check for genotyping for BDNF. For follow up evaluation, the investigators will keep up the psychiatric evaluation with HAM D, HAM A and peripheral proteinomic evaluation with platelet BDNF level, and other pro-inflammatory cytokines.
This research will figure out the correlation between neurotrophic factor as BDNF, and inflammatory factor seen in peripheral blood assay with treatment response in depression. Also the investigators are trying to integrate the peripheral change along with BDNF genotyping and specific change seen in neuroimaging. Replicating this research with high statistical power would be promising to find 'reliable peripheral marker for prognosis of depression'.
- Conditions
- Major Depressive Disorder
- Keywords
- Amyloid, BDNF, major depressive disorder, cognitive decline
- Medical subject headings
- Depressive Disorder, Major, Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| depression with cognitive impairment | depression onset after 60 years old with subjective cognitive impairment | |
| depression without cognitive impairment | depression onset after 60 years old without subjective cognitive impairment | |
| normal control | older than 65 years, free from other neurocognitive disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of Psychiatric symptom profile scores
Hamilton depression inventory 17 (HAM-D), Hamilton anxiety inventory (HAM-A) and peripheral proteinomic evaluation
Measured: baseline, 1month, 3months
Secondary outcomes (1)
The change of subjective Cognitive decline assessment profiles
Measured: baseline, 1month follow up, 3 months follow up, cognitive function assessment with subjective one and objective one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
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 Samsung Medical CenterThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Sungkyunkwan University, Korea University
- Responsible party
- Sponsor
- Investigators
- Hong Jin Jeon, M.D.,Ph.D., Principal investigator, Samsung Medical Center, Sungkyunkwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02983838
- Sponsor's protocol ID
- 2015-12-009
- Status last verified
- Nov 2016
- First submitted
- 13 Apr 2016
- Last updated
- 6 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Biomarker With Neuroimaging : Research on Pathophysiology and Treatment in Depression Using Brain Derived Neurotrophic Factor (BDNF) and Amyloid Neuroimaging
- ClinicalTrials.gov ID
- NCT02983838
- Acronym / sponsor ID
- 2015-12-009
- Conditions
- Major Depressive Disorder
- Keywords
- Amyloid, BDNF, major depressive disorder, cognitive decline
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Sungkyunkwan University, Korea University
- Study start
- Apr 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 6 Dec 2016 (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.
Target of the research Based on change of Brain-derived neurotrophic factor and other pro-inflammatory cytokine along with symptom improvement following treatment, the investigators are trying to find the new treatment target molecule. The investigators will follow up the subjective and objective cognitive dysfunction with psychiatric symptom profiles and compare the neuroimaging related to these change.
Detailed description
Recently the investigators reported the association between childhood trauma and refractory depression, which related to Brain Derived Neurotrophic Factor (BDNF). Even though level of peripheral BDNF is closely related to depression treatment, the investigators still have little idea on role of BDNF. In this research, the investigators are going to find the genetic variation affecting treatment response and process, figure out specific role of BDNF in depressive patient correlated with Neuroimaging. Along with BDNF, many kinds of proinflammatory cytokine showed increased amount related to depressive patient. Leptin, adiponectin, and plasma tryptohphan are also seen to be related to response of depression. Here, the investigators are trying to see specific difference on neuroimaging shown in depressive patient related to peripheral marker. The investigators will evaluate the 36 depressive patients compared to 24 normal control. For depressive patients, after excluding other bipolar spectrum disorder, psychotic disorder, other neurocognitive disorder, subjects who have organic brain lesion, tested as HAM D score above 16, will be included in this research. As a psychiatric evaluation, the investigators will do the MINI International Psychiatric Interview Plus (MINI Plus), Suicidal ideation evaluation, Hamilton Depression Inventory 17 (HAM D 17), Hamilton Anxiety Inventory (HAM A) to get the information of their clinical severity. As a neuroimaging evaluation, the investigators will do the magnetic resonance imaging (MRI) with diffusion tensor imaging and amyloid Positron Emission Tomography(PET) to see the specific deposition. For peripheral marker for inflammation and other neurotrophic factor, the investigators will do the platelet BDNF level,and other pre-inflammatory factors. The investigators will also check for genotyping for BDNF. For follow up evaluation, the investigators will keep up the psychiatric evaluation with HAM D, HAM A and peripheral proteinomic evaluation with platelet BDNF level, and other pro-inflammatory cytokines.
This research will figure out the correlation between neurotrophic factor as BDNF, and inflammatory factor seen in peripheral blood assay with treatment response in depression. Also the investigators are trying to integrate the peripheral change along with BDNF genotyping and specific change seen in neuroimaging. Replicating this research with high statistical power would be promising to find 'reliable peripheral marker for prognosis of depression'.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| depression with cognitive impairment | – | –depression onset after 60 years old with subjective cognitive impairment |
| depression without cognitive impairment | – | –depression onset after 60 years old without subjective cognitive impairment |
| normal control | – | –older than 65 years, free from other neurocognitive disorder |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- older than 65 years free from other main psychiatric diagnosis except major depressive disorder free from neurocognitive disorder normal control: older than 65 years
Key inclusion criteria (4 listed)
- Diagnosed as major depressive disorder with MINI and DSM-5 criteria whose age is more than 65 years
- Whose score of Hamilton Depression Scale is more than 16
- Whose first depressive episode onset was later than one's age of 60
- Who is free from antidepressants for 2 weeks
Key exclusion criteria (10 listed)
- Subjects with past history of Psychotic disorder or with present symptoms related to psychotic disorders
- Bipolar Spectrum Disorder
- With Neurocognitive disorder such as Parkinson's disease, Huntington's chorea, Mild Cognitive Disorder, or Dementia
- Who ever diagnosed as a Cognitive disability
- Who have serious medical condition which needs to be cared (e.g, cancer)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The change of Psychiatric symptom profile scores
Time frame: baseline, 1month, 3months
Hamilton depression inventory 17 (HAM-D), Hamilton anxiety inventory (HAM-A) and peripheral proteinomic evaluation
1 secondary outcome
The change of subjective Cognitive decline assessment profiles
Time frame: baseline, 1month follow up, 3 months follow up, cognitive function assessment with subjective one and objective one
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2016.
- Individual participant dataSharing planned: No
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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.
Hong Jin Jeon, M.D.,Ph.D. principal investigator
Samsung Medical Center, Sungkyunkwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder, run by Samsung Medical Center 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 4 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: status not confirmed, as of the sponsor's last update on 6 Dec 2016. 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.
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 Hong Jin Jeon, M.D.,Ph.D. (+82-2-3410-3586, jhj001001@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of Psychiatric symptom profile scores (time frame: baseline, 1month, 3months). 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 6 Dec 2016.