Neural-Derived Plasma Exosomal MicroRNAs As Promising Novel Biomarkers for Suicidality and Treatment Outcome in Adolescents

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

RECRUITING

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2027-06-30

Brief Summary

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This study is dedicated to help identify biomarkers for depression and suicide. The purpose of the study is to better understand these links to improve medical and psychiatric care in the future. This research is also to test the effects of standard treatment of depression on improvement in depressive and suicidal behavior and on biomarkers (e.g. miRNA) for these disorders.

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Detailed Description

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Conditions

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Major Depressive Disorder Suicidal Ideas Suicide, Attempted MDD Depression Depression, Teen Depression and Suicide Depression in Adolescence Suicide

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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MDD Participant

Participants with MDD will return at six weeks for a second blood draw and assessments

Group Type OTHER

Genetic testing

Intervention Type GENETIC

Attempting to identify the genetic biomarker that can identify risk for suicidal ideation and action

Interventions

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Genetic testing

Attempting to identify the genetic biomarker that can identify risk for suicidal ideation and action

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

All participants:

1. Physically healthy
2. willing and able to provide informed consent (if under 18 also parent or guardian consent)

MDD participants:

1. A definite diagnosis of DSM-5
2. a Children's Depression Rating Scale-Revised (CDRS-R) score \>=30. Suicidal ideation participants: Columbia Suicide Severity Rating Scale (C-SSRS) score \>=4 rated over the last two weeks.

Suicide attempt group:

1\. Participants will have had an attempt in the previous two weeks that is serious enough to require medical attention and shows evidence of at least a medium level of intent on the Suicide Intent Scale.

Non-psychiatric controls:

1\. No history of any major mental illness (excluding specific phobia) or substance use disorder.

Exclusion Criteria

1. Pregnancy or lactation
2. post-partum state (being within 2 months of delivery or miscarriage);
3. homicide risk as determined by clinical interview
4. any of the following DSM-V diagnoses or categories: a) a lifetime history of psychotic disorder; b) alcohol or drug use disorder (except nicotine/caffeine) within the last month; the use of any hallucinogen (except cannabis), including phencyclidine in the last month; c) bipolar disorder; d) pervasive developmental disorder; e) cognitive disorder; f) DSM-5 paranoid, schizoid, or schizotypal personality disorders (PDs) (participants with other PDs will be allowed as long as MDD criteria are met); g) anorexia nervosa.
5. recent myocardial infarction or unstable angina, active neoplasm in the past 6 months, immunosuppressive or corticosteroid therapy within the last month, chemotherapy, and head injury or loss of consciousness in the past 6 months
6. use of hallucinogens (except for cannabis), methamphetamine, or cocaine in the last 2 weeks.

Minimum Eligible Age

10 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes