Biomarkers of Antidepressant Response and Suicidal Events in Depressed Youth

NCT03547219 | Completed DMC

• 1 other identifier: 2015R1A2A2A01004501
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Adolescent

Keywords

Depression; Adolescent; Biomarker; Inflammation; Brain-derived neurotrophic factor (BDNF); Functional MRI; Antidepressant; Machine learning

Outcome Measures

Primary Outcomes (1)

• 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).

  baseline and 8 weeks or upon termination

Secondary Outcomes (1)

• CGI-I at 8 weeks or upon termination

  baseline and 8 weeks or upon termination

Study Arms (1)

Escitalopram

EXPERIMENTAL

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.

Drug: Escitalopram

Interventions

Escitalopram DRUG

Also known as: Lexapro

Escitalopram

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University: lead
• National Research Foundation of Korea: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, N/A = Not Applicable, 03080, South Korea

Location

Related Publications (1)

• 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.

  PMID: 33417814 DERIVED

MeSH Terms

Conditions

Depression; Inflammation

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jae-Won Kim, MD, PhD

  Seoul National University and Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 24, 2018
• First Posted: June 6, 2018
• Study Start: August 5, 2015
• Primary Completion: August 2, 2018
• Study Completion: August 2, 2018
• Last Updated: April 4, 2019

Record last verified: 2019-04

Locations

KR (1)