Neural-Derived Plasma Exosomal MicroRNAs As Promising Novel Biomarkers for Suicidality and Treatment Outcome in Adolescents
Primary Purpose
Major Depressive Disorder, Suicidal Ideas, Suicide, Attempted
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Genetic testing
Sponsored by
About this trial
This is an interventional prevention trial for Major Depressive Disorder
Eligibility Criteria
Inclusion Criteria:
All participants:
- Physically healthy
- willing and able to provide informed consent (if under 18 also parent or guardian consent)
MDD participants:
- A definite diagnosis of DSM-5
- 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:
Exclusion criteria:
- Pregnancy or lactation
- post-partum state (being within 2 months of delivery or miscarriage);
- homicide risk as determined by clinical interview
- 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.
- 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
- use of hallucinogens (except for cannabis), methamphetamine, or cocaine in the last 2 weeks.
Sites / Locations
- University of Alabama at BirminghamRecruiting
- UAB Huntsville Regional Medical CampusRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
MDD Participant
Arm Description
Participants with MDD will return at six weeks for a second blood draw and assessments
Outcomes
Primary Outcome Measures
Clinical phenotype analysis
Secondary Outcome Measures
Full Information
NCT ID
NCT05437588
First Posted
June 23, 2022
Last Updated
October 25, 2022
Sponsor
University of Alabama at Birmingham
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT05437588
Brief Title
Neural-Derived Plasma Exosomal MicroRNAs As Promising Novel Biomarkers for Suicidality and Treatment Outcome in Adolescents
Official Title
Neural-Derived Plasma Exosomal MicroRNAs As Promising Novel Biomarkers for Suicidality and Treatment Outcome in Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
June 29, 2027 (Anticipated)
Study Completion Date
June 30, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Suicidal Ideas, Suicide, Attempted, MDD, Depression, Depression, Teen, Depression and Suicide, Depression in Adolescence, Suicide
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MDD Participant
Arm Type
Other
Arm Description
Participants with MDD will return at six weeks for a second blood draw and assessments
Intervention Type
Genetic
Intervention Name(s)
Genetic testing
Intervention Description
Attempting to identify the genetic biomarker that can identify risk for suicidal ideation and action
Primary Outcome Measure Information:
Title
Clinical phenotype analysis
Time Frame
6 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All participants:
Physically healthy
willing and able to provide informed consent (if under 18 also parent or guardian consent)
MDD participants:
A definite diagnosis of DSM-5
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:
Exclusion criteria:
Pregnancy or lactation
post-partum state (being within 2 months of delivery or miscarriage);
homicide risk as determined by clinical interview
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.
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
use of hallucinogens (except for cannabis), methamphetamine, or cocaine in the last 2 weeks.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Allison Stewart, MA
Phone
256-551-4431
Email
allisonstewart@uabmc.edu
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Alexander
Email
lalexander@uabmc.edu
Facility Name
UAB Huntsville Regional Medical Campus
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brittany McCrory, BS
Phone
256-551-4657
Email
bamccrory@uabmc.edu
Phone
256-551-4431
Email
hsvpsychresearch@uabmc.edu
First Name & Middle Initial & Last Name & Degree
Yogesh Dwivedi, PhD
First Name & Middle Initial & Last Name & Degree
Richard C Shelton, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Neural-Derived Plasma Exosomal MicroRNAs As Promising Novel Biomarkers for Suicidality and Treatment Outcome in Adolescents
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