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OpenTrials
Completed

NCT Number: NCT03547219

Biomarkers of Antidepressant Response and Suicidal Events in Depressed Youth

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.

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Key information

Conditions

Depression Adolescent Behavior Behavioral Symptoms Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Escitalopram

Drug

Other names: Lexapro

Primary outcomes

  1. the change from baseline in CDRS-R at week 8 or upon termination

    Time frame: 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 outcomes

  1. CGI-I at 8 weeks or upon termination

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Seoul National University

Other

Collaborators

  • National Research Foundation of Korea

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jun 6, 2018
Registry last updated
Apr 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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