Biomarkers of Antidepressant Response and Suicidal Events in Depressed Youth

Depression Clinical Trial

Official title:

Biomarkers of Antidepressant Response and Suicidal Events in Depressed Youth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03547219
• Other study ID #: 2015R1A2A2A01004501
• Status: Completed
• Phase: N/A
• Start date: August 5, 2015
• Est. completion date: August 2, 2018

Study information

• Verified date: April 2019
• Source: Seoul National University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: August 2, 2018
• Est. primary completion date: August 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adolescent
• Depression

Intervention

Drug:
• Escitalopram

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul	N/A = Not Applicable

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University	National Research Foundation of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the change from baseline in CDRS-R at week 8 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).	baseline and 8 weeks or upon termination
Secondary	CGI-I at 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	baseline and 8 weeks or upon termination