Skip to main content
Clinical Trials/NCT02428439
NCT02428439
Unknown
Not Applicable

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

Asan Medical Center1 site in 1 country80 target enrollmentApril 2015

Overview

Phase
Not Applicable
Intervention
bupropion or lamotrigine
Conditions
Depression
Sponsor
Asan Medical Center
Enrollment
80
Locations
1
Primary Endpoint
Evaluation of Suicidal ideation and behavior
Last Updated
6 years ago

Overview

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)

Registry
clinicaltrials.gov
Start Date
April 2015
End Date
June 30, 2020
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hyo-Won Kim

Assistant professor, department of psychiatry, Asan Medical Center

Asan Medical Center

Eligibility Criteria

Inclusion Criteria

  • Aged between 11 and 18 years
  • Met the Kiddie-Schedule for Affective Disorders and Schizophrenia-Present and Lifetime Version (K-SADS-PL) diagnostic criteria for depressive episode or dysthymia
  • Intelligence quotient higher than 70 on the Korean Educational Developmental Institute's Wechsler Intelligence Scale for Children

Exclusion Criteria

  • presence of intellectual disability
  • presence of hereditary disorder
  • past and/or current history of acquired brain injury, like cerebral palsy
  • presence of seizure, other neurological disorder or sensory impairments
  • past and/or current history of pervasive developmental disorder
  • past and/or current history of schizophrenia, bipolar disorder or psychosis
  • presence of severe learning disorder

Arms & Interventions

Increased suicidality

Increase in suicidal ideation after taking the standardized pharmacotherapy (bupropion or lamotrigine) during 8 weeks.

Intervention: bupropion or lamotrigine

Non-increased suicidality

Non-increase of suicidal ideation after taking the standardized pharmacotherapy (bupropion or lamotrigine) during 8 weeks.

Intervention: bupropion or lamotrigine

Outcomes

Primary Outcomes

Evaluation of Suicidal ideation and behavior

Time Frame: 8 weeks

Using Columbia-Suicide Severity Rating Scale(C-SSRS)

Secondary Outcomes

  • Evaluation of treatment effect of antidepressants(CDRS)(8 weeks)
  • Evaluation of treatment effect of antidepressants (YMRS)(8 weeks)
  • Evaluation of treatment effect of antidepressants(P-GBI)(8 weeks)
  • Evaluation of treatment effect of antidepressants(CGI-S)(8 weeks)
  • Genome wide association analysis(8 weeks)

Study Sites (1)

Loading locations...

Similar Trials