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Biomarkers of Antidepressant Response and Suicidal Events in Depressed Youth

Primary Purpose

Depression, Adolescent

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Escitalopram
Sponsored by
Seoul National University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Depression focused on measuring Depression, Adolescent, Biomarker, Inflammation, Brain-derived neurotrophic factor (BDNF), Functional MRI, Antidepressant, Machine learning

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • clinical diagnosis of major depressive disorder(MDD) according to criteria of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
  • current episode at least 4 weeks in duration at baseline
  • with a score of at least 40 on the Children's Depression Rating Scale-Revised (CDRS-R), and CGI-Severity ≥4 at baseline

Exclusion Criteria:

  • intelligence quotient (IQ) lower than 70
  • psychotic features or first-degree relatives with a history of bipolar I disorder
  • alcohol or substance abuse within the past 6 months
  • history of schizophrenia, bipolar disorder, eating disorder, or autism
  • history of neurological diseases including convulsive disorders or brain damage
  • concurrent medications with psychotropic effects (other than stimulants for ADHD)
  • chronic medical conditions (e.g., asthma, inflammatory bowel disease, diabetes) and/or chronic medication with psychotropic effects (e.g., anticonvulsants) or chronic use of NSAIDS or other drugs with known impact on inflammatory pathways.

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Escitalopram

Arm Description

Participants with depression were treated with escitalopram(ranging from 5mg to 30mg) for 8 weeks. Escitalopram was initiated at 5mg for 1 week, followed by an increase to 10mg at week 2. After week 2, doses of escitalopram were titrated according to symptoms and adverse effects. Specific, indicated psychotherapy for depression was not allowed during the study.

Outcomes

Primary Outcome Measures

the change from baseline in CDRS-R at week 8 or upon termination
The Children's Depression Rating Scale-Revised (CDRS-R) is a clinician-rated scale to measure the severity of depression of children and adolescents. The CDRS-R consists of 17 items. Depression symptoms are rated on a 5-point scale from 1 to 5 for sleep, appetite, and tempo of speech items and a 7-point scale from 1 to 7 for remaining 14 items. The total score ranges form 17 (normal) to 113 (severe depression). Change from baseline CDRS-R at 8 weeks or upon termination was calculated as baseline minus 8 weeks in the adjusted CDRS-R total score (CDRS-R total minus 17, the minimum possible total score).

Secondary Outcome Measures

CGI-I at 8 weeks or upon termination
The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1=very much improved; 2= much improved; 3=minimally improved; 4=no change from baseline; 5=minimally worse; 6=much worse; 7=very much worse since the initiation of treatment. CGI-I was measured at 8 weeks or upon termination

Full Information

First Posted
May 24, 2018
Last Updated
April 2, 2019
Sponsor
Seoul National University
Collaborators
National Research Foundation of Korea
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1. Study Identification

Unique Protocol Identification Number
NCT03547219
Brief Title
Biomarkers of Antidepressant Response and Suicidal Events in Depressed Youth
Official Title
Biomarkers of Antidepressant Response and Suicidal Events in Depressed Youth
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
August 5, 2015 (Actual)
Primary Completion Date
August 2, 2018 (Actual)
Study Completion Date
August 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University
Collaborators
National Research Foundation of Korea

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aims of this study are to (1) identify inflammatory/neurotrophic and neurodevelopmental markers that predict antidepressant response and suicidal risk in depressed youth and (2) predict their treatment response and the occurrence of suicidal events at the individual level using machine learning approach.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Adolescent
Keywords
Depression, Adolescent, Biomarker, Inflammation, Brain-derived neurotrophic factor (BDNF), Functional MRI, Antidepressant, Machine learning

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
152 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Escitalopram
Arm Type
Experimental
Arm Description
Participants with depression were treated with escitalopram(ranging from 5mg to 30mg) for 8 weeks. Escitalopram was initiated at 5mg for 1 week, followed by an increase to 10mg at week 2. After week 2, doses of escitalopram were titrated according to symptoms and adverse effects. Specific, indicated psychotherapy for depression was not allowed during the study.
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Other Intervention Name(s)
Lexapro
Primary Outcome Measure Information:
Title
the change from baseline in CDRS-R at week 8 or upon termination
Description
The Children's Depression Rating Scale-Revised (CDRS-R) is a clinician-rated scale to measure the severity of depression of children and adolescents. The CDRS-R consists of 17 items. Depression symptoms are rated on a 5-point scale from 1 to 5 for sleep, appetite, and tempo of speech items and a 7-point scale from 1 to 7 for remaining 14 items. The total score ranges form 17 (normal) to 113 (severe depression). Change from baseline CDRS-R at 8 weeks or upon termination was calculated as baseline minus 8 weeks in the adjusted CDRS-R total score (CDRS-R total minus 17, the minimum possible total score).
Time Frame
baseline and 8 weeks or upon termination
Secondary Outcome Measure Information:
Title
CGI-I at 8 weeks or upon termination
Description
The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1=very much improved; 2= much improved; 3=minimally improved; 4=no change from baseline; 5=minimally worse; 6=much worse; 7=very much worse since the initiation of treatment. CGI-I was measured at 8 weeks or upon termination
Time Frame
baseline and 8 weeks or upon termination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: clinical diagnosis of major depressive disorder(MDD) according to criteria of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) current episode at least 4 weeks in duration at baseline with a score of at least 40 on the Children's Depression Rating Scale-Revised (CDRS-R), and CGI-Severity ≥4 at baseline Exclusion Criteria: intelligence quotient (IQ) lower than 70 psychotic features or first-degree relatives with a history of bipolar I disorder alcohol or substance abuse within the past 6 months history of schizophrenia, bipolar disorder, eating disorder, or autism history of neurological diseases including convulsive disorders or brain damage concurrent medications with psychotropic effects (other than stimulants for ADHD) chronic medical conditions (e.g., asthma, inflammatory bowel disease, diabetes) and/or chronic medication with psychotropic effects (e.g., anticonvulsants) or chronic use of NSAIDS or other drugs with known impact on inflammatory pathways.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae-Won Kim, MD, PhD
Organizational Affiliation
Seoul National University and Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
N/A = Not Applicable
ZIP/Postal Code
03080
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
33417814
Citation
Choi CH, Lee J, Lee KH, Hong SB, Kim SH, Han JY, Kim JW, Cho SC, Kim JW. Effects of Antidepressant Treatment on Symptom Measures of Attention in Adolescents with Depression: A Preliminary Open-Label Study. J Child Adolesc Psychopharmacol. 2021 May;31(4):288-293. doi: 10.1089/cap.2020.0101. Epub 2021 Jan 8.
Results Reference
derived

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Biomarkers of Antidepressant Response and Suicidal Events in Depressed Youth

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