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

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ClinicalTrials.gov Identifier: NCT02428439
Recruitment Status : Recruiting
First Posted : April 28, 2015
Last Update Posted : January 10, 2018
Sponsor:
Information provided by (Responsible Party):
Hyo-Won Kim, 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)

Condition or disease Intervention/treatment
Depression Suicidal Ideation Drug: bupropion or lamotrigine

Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Genetic Markers and Predictors of Antidepressant-induced Suicidality in Youth Depression
Study Start Date : April 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Increased suicidality
Increase in suicidal ideation after taking the standardized pharmacotherapy (bupropion or lamotrigine) during 8 weeks.
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.
Other Names:
  • Wellbutrin
  • Lamictal

Non-increased suicidality
Non-increase of suicidal ideation after taking the standardized pharmacotherapy (bupropion or lamotrigine) during 8 weeks.
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.
Other Names:
  • Wellbutrin
  • Lamictal




Primary Outcome Measures :
  1. Evaluation of Suicidal ideation and behavior [ Time Frame: 8 weeks ]
    Using Columbia-Suicide Severity Rating Scale(C-SSRS)


Secondary Outcome Measures :
  1. Evaluation of treatment effect of antidepressants(CDRS) [ Time Frame: 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.

  2. Evaluation of treatment effect of antidepressants (YMRS) [ Time Frame: 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.

  3. Evaluation of treatment effect of antidepressants(P-GBI) [ Time Frame: 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.

  4. Evaluation of treatment effect of antidepressants(CGI-S) [ Time Frame: 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.

  5. Genome wide association analysis [ Time Frame: 8 weeks ]
    KNIH Biobank Array


Biospecimen Retention:   Samples With DNA
whole blood sample for GWAS(Genome-Wide Association Study)


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Ages Eligible for Study:   11 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children and adolescents between 11 years and 18 years in depressed psychiatric outpatients.

increased suicidal ideation: 14 people, non-increased suicidal ideation: 54 people, patient drop-out rate: 20%, total 80 people.

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02428439


Contacts
Contact: lee myungeun, BA +82-2-3010-7190 lme23@amc.seoul.kr
Contact: Sojung Park, BA +82-2-3010-7190 sojung@amc.seoul.kr

Locations
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Contact: Hyo-Won Kim    82-2-3010-3414    shingubi@amc.seoul.kr   
Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: Hyowon Kim, Professor Asan Medical Center

Responsible Party: Hyo-Won Kim, Assistant professor, department of psychiatry, Asan Medical Center, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02428439     History of Changes
Other Study ID Numbers: S2015-0305-0003
First Posted: April 28, 2015    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Hyo-Won Kim, Asan Medical Center:
genetic markers
predictors
Antidepressive Agents
Suicidal Ideation
Adolescent

Additional relevant MeSH terms:
Depression
Depressive Disorder
Suicidal Ideation
Behavioral Symptoms
Mood Disorders
Mental Disorders
Suicide
Self-Injurious Behavior
Antidepressive Agents
Bupropion
Lamotrigine
Anticonvulsants
Psychotropic Drugs
Antidepressive Agents, Second-Generation
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Calcium Channel Blockers
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers