Trial | NCT03547219  Report issue

Official Title

Biomarkers of Antidepressant Response and Suicidal Events in Depressed Youth

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    152
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 Started
Aug 05
2015
Primary Completion
Aug 02
2018
Study Completion
Aug 02
2018
Last Update
Apr 04
2019

Drug Escitalopram

  • Other names: Lexapro

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.

Criteria 

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.
No Results Posted