Biomarkers of Antidepressant Response and Suicidal Events in Depressed Youth

Not Applicable

Completed

• Conditions: Depression; Adolescent
• Interventions: Drug: Escitalopram

• Registration Number: NCT03547219
• Lead Sponsor: Seoul National University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-05
• Study First Submitted: 2018-05-24
• Study First Submitted QC: 2018-05-24
• Study First Posted: 2018-06-06
• Primary Completion: 2018-08-02
• Study Completion: 2018-08-02
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-02
• Last Update Posted: 2019-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Escitalopram	Escitalopram	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.

Primary Outcome Measures

Name	Time	Method
the change from baseline in CDRS-R at week 8 or upon termination	baseline and 8 weeks 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

Name	Time	Method
CGI-I at 8 weeks or upon termination	baseline and 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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, N/A = Not Applicable, Korea, Republic of