- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02983838
Research on Pathophysiology and Treatment in Depression Using Brain Derived Neurotrophic Factor and Amyloid Neuroimaging
Development of Biomarker With Neuroimaging : Research on Pathophysiology and Treatment in Depression Using Brain Derived Neurotrophic Factor (BDNF) and Amyloid Neuroimaging
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Irwon-dong, Gangnam-gu
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Seoul, Irwon-dong, Gangnam-gu, Korea, Republic of, 135710
- Recruiting
- Samsung Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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depression with cognitive impairment
depression onset after 60 years old with subjective cognitive impairment
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depression without cognitive impairment
depression onset after 60 years old without subjective cognitive impairment
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normal control
older than 65 years, free from other neurocognitive disorder
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The change of Psychiatric symptom profile scores
Time Frame: baseline, 1month, 3months
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Hamilton depression inventory 17 (HAM-D), Hamilton anxiety inventory (HAM-A) and peripheral proteinomic evaluation
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baseline, 1month, 3months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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baseline, 1month follow up, 3 months follow up, cognitive function assessment with subjective one and objective one
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hong Jin Jeon, M.D.,Ph.D., Samsung Medical Center, Sungkyunkwan University
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-12-009
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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