Research on Pathophysiology and Treatment in Depression Using Brain Derived Neurotrophic Factor and Amyloid Neuroimaging

NCT02983838 | Unknown DMC

• 1 other identifier: 2015-12-009
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. The investigators will follow up the subjective and objective cognitive dysfunction with psychiatric symptom profiles and compare the neuroimaging related to these change.

Conditions

Major Depressive Disorder

Keywords

Amyloid; BDNF; major depressive disorder; cognitive decline

Outcome Measures

Primary Outcomes (1)

• The change of Psychiatric symptom profile scores

  Hamilton depression inventory 17 (HAM-D), Hamilton anxiety inventory (HAM-A) and peripheral proteinomic evaluation

  baseline, 1month, 3months

Secondary Outcomes (1)

• The change of subjective Cognitive decline assessment profiles

  baseline, 1month follow up, 3 months follow up, cognitive function assessment with subjective one and objective one

Study Arms (3)

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

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead
• Sungkyunkwan University: collaborator
• Korea University: collaborator

Study Sites (1)

Samsung Medical Center

Seoul, Irwon-dong, Gangnam-gu, 135710, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood specimen for pro-inflammatory cytokine and BDNF BDNF genotyping

MeSH Terms

Conditions

Depressive Disorder, Major; Alzheimer Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Cognition Disorders

Study Officials

• Hong Jin Jeon, M.D.,Ph.D.

  Samsung Medical Center, Sungkyunkwan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hong Jin Jeon, M.D.,Ph.D.

CONTACT

+82-2-3410-3586; jhj001001@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2016
• First Posted: December 6, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 6, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)