Biomarkers of Antidepressant Response and Suicidal Events in Depressed Youth

Seoul National University

Status: Completed

Conditions: Adolescent; Depression

Treatments: Drug: Escitalopram

Study type: Interventional

Funder types: Other

Identifiers

NCT03547219

2015R1A2A2A01004501

Details and patient eligibility

About

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.

Enrollment: 152 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No 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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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152 participants in 1 patient group

Escitalopram

Experimental group

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.

Treatment:

Drug: Escitalopram