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NMDA Receptor Antagonist
MDD without Suicidal Ideation no attempt for Depression
Phase 2
Waitlist Available
Led By Yogesh Dwivedi, Ph.D.
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 180 minutes post dose
Awards & highlights
Study Summary
This trial is examining whether microRNAs present in neural-derived exosomes are differentially expressed in subjects with suicidal ideation or behavior, and whether these microRNAs are associated with response to ketamine.
Eligible Conditions
- Depression
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 180 minutes post dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~180 minutes post dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Beck Scale for Suicide Ideation (BSS)
Secondary outcome measures
4-item Brief Psychiatric Rating Scale (BPRS)
Beck Anxiety Inventory (BAI)
Beck Depression Inventory (BDI)
+5 moreTrial Design
4Treatment groups
Active Control
Group I: MDD without Suicidal Ideation no attemptActive Control1 Intervention
All subjects with Major Depressive Disorder without recent Suicidal Ideation (in the past 7 days) without a recent Suicide Attempt (in the past 6 months) will receive a one-time IV infusion of ketamine at a dose of 0.5mg/kg at a rate of 40mL over 40 minutes. Blood will be drawn at pre-dose, 30 minutes post dose, 180 minutes post dose, 24 hours post dose, and 14 days post dose to measure changes in miRNAs.
Group II: MDD with Suicidal Ideation no attemptActive Control1 Intervention
All subjects with Major Depressive Disorder with recent Suicidal Ideation (in the past 7 days) without a recent Suicide Attempt (in the past 6 months) will receive a one-time IV infusion of ketamine at a dose of 0.5mg/kg at a rate of 40mL over 40 minutes. Blood will be drawn at pre-dose, 30 minutes post dose, 180 minutes post dose, 24 hours post dose, and 14 days post dose to measure changes in miRNAs.
Group III: Healthy ControlsActive Control1 Intervention
Healthy Control subjects without a psychiatric diagnosis will have a one-time blood draw to examine miRNAs.
Group IV: MDD with recent Suicide AttemptActive Control1 Intervention
All subjects with Major Depressive Disorder with a recent Suicide Attempt (in the past 2 weeks) will receive a one-time IV infusion of ketamine at a dose of 0.5mg/kg at a rate of 40 milliliters (mL) over 40 minutes. Blood will be drawn at pre-dose, 30 minutes post dose, 180 minutes post dose, 24 hours post dose, and 14 days post dose to measure changes in miRNAs.
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Who is running the clinical trial?
National Institute of Mental Health (NIMH)NIH
2,786 Previous Clinical Trials
2,689,452 Total Patients Enrolled
667 Trials studying Depression
251,584 Patients Enrolled for Depression
University of Alabama at BirminghamLead Sponsor
1,590 Previous Clinical Trials
2,281,215 Total Patients Enrolled
24 Trials studying Depression
2,629 Patients Enrolled for Depression
Yogesh Dwivedi, Ph.D.Principal InvestigatorUniversity of Alabama at Birmingham
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