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

• Conditions: Suicidal Ideation; Depression
• Interventions: Drug: bupropion or lamotrigine

• Registration Number: NCT02428439
• Lead Sponsor: Asan Medical Center

Brief 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)

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-20
• Study First Submitted QC: 2015-04-23
• Study First Posted: 2015-04-28
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-02
• Last Update Posted: 2019-07-05
• Primary Completion: 2019-12-31
• Study Completion: 2020-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Increased suicidality	bupropion or lamotrigine	Increase in suicidal ideation after taking the standardized pharmacotherapy (bupropion or lamotrigine) during 8 weeks.
Non-increased suicidality	bupropion or lamotrigine	Non-increase of suicidal ideation after taking the standardized pharmacotherapy (bupropion or lamotrigine) during 8 weeks.

Primary Outcome Measures

Name	Time	Method
Evaluation of Suicidal ideation and behavior	8 weeks	Using Columbia-Suicide Severity Rating Scale(C-SSRS)

Secondary Outcome Measures

Name	Time	Method
Evaluation of treatment effect of antidepressants(CDRS)	8 weeks	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.
Evaluation of treatment effect of antidepressants (YMRS)	8 weeks	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.
Evaluation of treatment effect of antidepressants(P-GBI)	8 weeks	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.
Evaluation of treatment effect of antidepressants(CGI-S)	8 weeks	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.
Genome wide association analysis	8 weeks	KNIH Biobank Array

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of