miRNAs, Suicide, and Ketamine - Plasma Exosomal microRNAs as Novel Biomarkers for Suicidality and Treatment Outcome
Major Depressive Disorder
About this trial
This is an interventional basic science trial for Major Depressive Disorder focused on measuring Depression, Ketamine, Suicide Attempt, Suicidal Ideation, Suicidality
Eligibility Criteria
Inclusion Criteria:
- Age 18-65
- Physically healthy and capable of undergoing ketamine infusion
- Willing and able to provide informed consent
- Diagnosis of Major Depressive Episode (MDE) as determined by the Mini International Neuropsychiatric Interview (MINI) (MDD participants)
- Hamilton Depression Rating Scale (HAM-D) 21 score ≥ 16 (MDD participants)
- Suicide attempt occurred within past 2 weeks (MDD Participants with Suicide Attempt)
- For the time frame of the past 7 days, Columbia-Suicide Severity Rating Scale (C-SSRS) score ≥ 3 (MDD Participants without Suicide Attempt, with Suicidal Ideation)
- For the time frame of the past 7 days, C-SSRS score < 3 (MDD Participants without Suicide Attempt, without SUicidal Ideation)
Exclusion Criteria:
- Pregnancy or lactation
- Post-partum state (being within 2 months of delivery or miscarriage)
- Homicide risk as determined by clinical interview
- A lifetime history of psychotic disorder
- Any history of dissociation or dissociative disorder
- Bipolar disorder
- Pervasive developmental disorder
- Cognitive disorder
- Cluster A personality disorder
- Anorexia nervosa
- Treatment with one of the following medications, known to affect the glutamate-N-methyl-D-aspartate (NMDA) receptor system (specifically: lamotrigine, acamprosate, memantine, riluzole, or lithium)
- Alcohol or drug dependence (except nicotine and caffeine) within the last month or the use of any hallucinogen (except cannabis), including phencyclidine in the last month
- Any known hypersensitivity or serious adverse effect associated with ketamine treatment
- Any clinically-significant medication condition or therapy that would preclude treatment with ketamine, to include: Recent myocardial infarction
- Unstable angina
- Active neoplasm in the past 6 months
- Immunosuppressive or corticosteroid therapy within the last month, with the following exceptions: any inhaled, intranasal, topical or vaginal corticosteroids are allowed.
- Chemotherapy
- Head injury of loss of consciousness in the past 6 months
If the subject reports any of the following disorders:
- Rheumatoid arthritis
- Lupus erythematosus
- Autoimmune hepatitis
- Autoimmune peripheral neuropathy
- Autoimmune pancreatitis
- Behcet's disease
- Chrohn's disease
- Autoimmune glomerulonephritis
- Grave's disease
- Guillain-Barre syndrome (if active)
- Hashimoto's thyroiditis
- Autoimmune polymyositis or polymyalgia (fibromyalgia is OK)
- Myasthenia gravis
- Narcolepsy
- Polyarteritis nodosa
- Scleroderma
- Sjogren's syndrome
- Transverse myelitis
- Wegener's granulomatosis
- HIstory of seizures (only childhood febrile seizures allowed)
- (HIV and Hepatitis are OK if stable)
- Systolic blood pressure > 150 and/or diastolic blood pressure >90 at screening
- A Corrected QT Interval (QTc) > 480 msec as determined by an ECG
Sites / Locations
- University of Alabama at Birmingham
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Active Comparator
No Intervention
MDD with recent Suicide Attempt
MDD with Suicidal Ideation no attempt
MDD without Suicidal Ideation no attempt
Healthy Controls
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.
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.
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.
Healthy Control subjects without a psychiatric diagnosis will have a one-time blood draw to examine miRNAs.