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

NCT ID: NCT02428439

Last Updated: 2019-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Study Completion Date

2020-06-30

Brief Summary

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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

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Conditions

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Depression Suicidal Ideation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Increased suicidality

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

bupropion or lamotrigine

Intervention Type DRUG

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.

Non-increased suicidality

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

bupropion or lamotrigine

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Wellbutrin Lamictal

Eligibility Criteria

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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
Minimum Eligible Age

11 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Hyo-Won Kim

Assistant professor, department of psychiatry, Asan Medical Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hyowon Kim, Professor

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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lee myungeun, BA

Role: CONTACT

+82-2-3010-7190

Sojung Park, BA

Role: CONTACT

+82-2-3010-7190

Facility Contacts

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Hyo-Won Kim

Role: primary

82-2-3010-3414

Other Identifiers

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S2015-0305-0003

Identifier Type: -

Identifier Source: org_study_id

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