Biomarkers of Antidepressant Response and Suicidal Events in Depressed Youth

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

COMPLETED

Clinical Phase

NA

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-05

Study Completion Date

2018-08-02

Brief Summary

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The aims of this study are to (1) identify inflammatory/neurotrophic and neurodevelopmental markers that predict antidepressant response and suicidal risk in depressed youth and (2) predict their treatment response and the occurrence of suicidal events at the individual level using machine learning approach.

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Detailed Description

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Conditions

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Depression Adolescent

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Escitalopram

Participants with depression were treated with escitalopram(ranging from 5mg to 30mg) for 8 weeks. Escitalopram was initiated at 5mg for 1 week, followed by an increase to 10mg at week 2. After week 2, doses of escitalopram were titrated according to symptoms and adverse effects. Specific, indicated psychotherapy for depression was not allowed during the study.

Group Type EXPERIMENTAL

Escitalopram

Intervention Type DRUG

Interventions

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Escitalopram

Intervention Type DRUG

Other Intervention Names

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Lexapro

Eligibility Criteria

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Inclusion Criteria

* clinical diagnosis of major depressive disorder(MDD) according to criteria of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
* current episode at least 4 weeks in duration at baseline
* with a score of at least 40 on the Children's Depression Rating Scale-Revised (CDRS-R), and CGI-Severity ≥4 at baseline

Exclusion Criteria

* intelligence quotient (IQ) lower than 70
* psychotic features or first-degree relatives with a history of bipolar I disorder
* alcohol or substance abuse within the past 6 months
* history of schizophrenia, bipolar disorder, eating disorder, or autism
* history of neurological diseases including convulsive disorders or brain damage
* concurrent medications with psychotropic effects (other than stimulants for ADHD)
* chronic medical conditions (e.g., asthma, inflammatory bowel disease, diabetes) and/or chronic medication with psychotropic effects (e.g., anticonvulsants) or chronic use of NSAIDS or other drugs with known impact on inflammatory pathways.

Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No