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Genetic Testing for Depression and Suicide Risk Management
N/A
Recruiting
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
11-18 Years Old?
Be younger than 65 years old
Must not have
You have been diagnosed with Bipolar Disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trialstudies biomarkers to understand depression and suicide better, to improve treatment and care in the future. It tests how treatments can improve depressive and suicidal behavior.
Who is the study for?
This trial is for physically healthy adolescents with major depressive disorder (MDD) and a high risk of suicide, who can provide informed consent. It includes those who recently attempted suicide or have severe suicidal thoughts. Participants must not have certain mental health conditions, recent serious physical health issues, or substance use disorders.
What is being tested?
The study aims to identify new biomarkers in the blood related to depression and suicidality by using genetic testing on exosomes derived from nerve cells. It will also assess how standard treatments for depression affect these potential biomarkers and patient outcomes.
What are the potential side effects?
Since this trial involves genetic testing rather than drug treatment, there are no direct side effects associated with the intervention itself. However, participants may experience discomfort or other minor effects from the blood draw required for the test.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowExclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Clinical phenotype analysis
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: MDD ParticipantExperimental Treatment1 Intervention
Participants with MDD will return at six weeks for a second blood draw and assessments
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Genetic testing
2017
N/A
~5890
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,646 Previous Clinical Trials
2,342,709 Total Patients Enrolled
24 Trials studying Depression
4,642 Patients Enrolled for Depression
National Institute of Mental Health (NIMH)NIH
2,918 Previous Clinical Trials
2,739,725 Total Patients Enrolled
701 Trials studying Depression
260,911 Patients Enrolled for Depression
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with major depression, have significant symptoms, and have thought about suicide recently.I haven't had a heart attack, unstable angina, cancer, immunosuppressants, steroids, chemotherapy, or head injuries in the last 6 months.I am healthy, willing to participate, and can give my consent (or have a guardian who can if I'm under 18).I am in good physical health.I have been diagnosed with major depressive disorder.
Research Study Groups:
This trial has the following groups:- Group 1: MDD Participant
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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