Biomarkers of Antidepressant Response and Suicidal Events in Depressed Youth
Overview
- Phase
- Not Applicable
- Intervention
- Escitalopram
- Conditions
- Depression
- Sponsor
- Seoul National University
- Enrollment
- 152
- Locations
- 1
- Primary Endpoint
- the change from baseline in CDRS-R at week 8 or upon termination
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Jae-Won Kim
Professor
Seoul National University
Eligibility 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.
Arms & Interventions
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.
Intervention: Escitalopram
Outcomes
Primary Outcomes
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
- CGI-I at 8 weeks or upon termination(baseline and 8 weeks or upon termination)