Biomarkers of Antidepressant Response and Suicidal Events in Depressed Youth

Seoul National University152 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

152

Conditions

Depression Adolescent

Interventions

EscitalopramDRUG

Eligibility

Sex: ALLMin age: 12 YearsMax age: 17 Years

Medical Language ↔ Plain English

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.

Locations (1)

Seoul National University Hospital

Seoul, N/A = Not Applicable, South Korea

Outcomes

Primary Outcomes

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).

Time frame: baseline and 8 weeks or upon termination

Secondary Outcomes

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

Time frame: baseline and 8 weeks or upon termination

Data from ClinicalTrials.gov

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