Identification of Genetic Markers and Predictors of Antidepressant-induced Suicidality in Youth Depression

Depression Clinical Trial

Official title:

Genetic Markers and Predictors of Antidepressant-induced Suicidality in Youth Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02428439
• Other study ID #: S2015-0305-0003
• Status: Recruiting
• Start date: April 2015
• Est. completion date: June 30, 2020

Study information

• Verified date: July 2019
• Source: Asan Medical Center
• Contact: lee myungeun, BA
• Phone: +82-2-3010-7190
• Email: lme23[@]amc.seoul.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of this study is to identification of genetic markers and predictors of antidepressant-induced suicidality in youth depression. Participants who take the standardized pharmacotherapy (bupropion or lamotrigine) for depression will be observed for 8 weeks. They will do several scales and genetic tests at visit 1 (week 0), visit 3 (week 4) and visit 4 (week 8)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 30, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 18 Years

Eligibility

Inclusion Criteria:

1. Aged between 11 and 18 years

2. Met the Kiddie-Schedule for Affective Disorders and Schizophrenia-Present and Lifetime Version (K-SADS-PL) diagnostic criteria for depressive episode or dysthymia

3. Intelligence quotient higher than 70 on the Korean Educational Developmental Institute's Wechsler Intelligence Scale for Children

Exclusion Criteria:

1. presence of intellectual disability

2. presence of hereditary disorder

3. past and/or current history of acquired brain injury, like cerebral palsy

4. presence of seizure, other neurological disorder or sensory impairments

5. past and/or current history of pervasive developmental disorder

6. past and/or current history of schizophrenia, bipolar disorder or psychosis

7. presence of severe learning disorder

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Suicidal Ideation

Intervention

Drug:
• bupropion or lamotrigine
Participants who take the standardized pharmacotherapy (bupropion or lamotrigine) for depression will be observed for 8 weeks. Drugs using in this study are the standard treatment for depression, and are NOT administered as part of this study.

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of Suicidal ideation and behavior	Using Columbia-Suicide Severity Rating Scale(C-SSRS)	8 weeks
Secondary	Evaluation of treatment effect of antidepressants(CDRS)	A composite measure consisting of Children's Depression Rating scale(CDRS). Modeled after the Hamilton Rating Scale for Depression, the CDRS is a clinical interview tool designed for assessing 6-12 year-olds, and it has also been used successfully for adolescents.	8 weeks
Secondary	Evaluation of treatment effect of antidepressants (YMRS)	A composite measure consisting of Young Mania Rating Scale(YMRS). The YMRS is an 11-item scale used to assess the severity of mania in children and adolescents ages 5-17.The YMRS has been used in clinical practice since 1978. Ratings are based on child/adolescent self-reporting and clinician observation. This instrument does not assess depressed mood.	8 weeks
Secondary	Evaluation of treatment effect of antidepressants(P-GBI)	The P-GBI is adapted from the General Behavior Inventory, and allows parents to rate depressive, hypomanic, manic, and alternating mood symptoms in their children and adolescents ages 5-17.	8 weeks
Secondary	Evaluation of treatment effect of antidepressants(CGI-S)	The Clinical Global Impression rating scales(CGI-S) are commonly used measures of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders.	8 weeks
Secondary	Genome wide association analysis	KNIH Biobank Array	8 weeks