Clinical TrialSuicidalityKetamineKetamineKetamineCompleted

miRNAs, Suicide, and Ketamine – Plasma Exosomal microRNAs as Novel Biomarkers for Suicidality and Treatment Outcome

Parallel Phase II study (n=247) comparing neural-exosomal miRNAs in three MDD groups (recent attempt, suicidal ideation, no ideation) given a single IV ketamine infusion (0.5 mg/kg) and healthy controls with one-time blood draw.

Target Enrollment
247 participants
Study Type
Phase II interventional
Design
Non-randomized

Detailed Description

Parallel-group study enrolling MDD participants with recent suicide attempt, MDD with serious suicidal ideation, MDD without significant ideation, and healthy controls; MDD groups receive a single IV ketamine infusion (0.5 mg/kg over 40 minutes).

Blood samples for neural-derived exosomal miRNA analysis are collected pre-infusion, 30 minutes, 180 minutes, 24 hours and 14 days post-infusion; healthy controls provide a single blood draw. The aim is to identify miRNA signatures associated with suicidality and ketamine treatment response.

Data collection is complete as of July 2022 and analysis was ongoing as of May–July 2022; final outcomes will be reported upon completion of analyses.

Study Protocol

Preparation

1 sessions

Dosing

1 sessions
40 min each

Integration

0 sessions

Study Arms & Interventions

MDD Recent Attempt

active comparator

MDD participants with a suicide attempt in past 2 weeks receiving single IV ketamine infusion.

Interventions

  • Ketamine0.5 mg/kg
    via IV• single dose

    Infusion 0.5 mg/kg delivered over 40 minutes (rate ~40 mL over 40 min). Blood at pre, 30 min, 180 min, 24 h, 14 days.

MDD Suicidal Ideation

active comparator

MDD participants with serious ideation (past 7 days) without recent attempt receiving single IV ketamine infusion.

Interventions

  • Ketamine0.5 mg/kg
    via IV• single dose

    Infusion 0.5 mg/kg over 40 minutes; blood draws at pre, 30 min, 180 min, 24 h, 14 days.

MDD No Ideation

active comparator

MDD participants without recent ideation or attempt receiving single IV ketamine infusion.

Interventions

  • Ketamine0.5 mg/kg
    via IV• single dose

    Infusion 0.5 mg/kg over 40 minutes; blood draws at pre, 30 min, 180 min, 24 h, 14 days.

Healthy Controls

waitlist

Healthy control participants with one-time blood draw; no ketamine.

Interventions

  • Compound

    One-time blood draw; no ketamine.

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 1. Age 18-65
  • 2. Physically healthy and capable of undergoing ketamine infusion
  • 3. Willing and able to provide informed consent
  • 4. Diagnosis of Major Depressive Episode (MDE) as determined by the Mini International Neuropsychiatric Interview (MINI) (MDD participants)
  • 5. Hamilton Depression Rating Scale (HAM-D) 21 score ≥ 16 (MDD participants)
  • 6. Suicide attempt occurred within past 2 weeks (MDD Participants with Suicide Attempt)
  • 7. 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)
  • 8. For the time frame of the past 7 days, C-SSRS score < 3 (MDD Participants without Suicide Attempt, without Suicidal Ideation)

Exclusion Criteria

  • 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. A lifetime history of psychotic disorder
  • 5. Any history of dissociation or dissociative disorder
  • 6. Bipolar disorder
  • 7. Pervasive developmental disorder
  • 8. Cognitive disorder
  • 9. Cluster A personality disorder
  • 10. Anorexia nervosa
  • 11. 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)
  • 12. 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
  • 13. Any known hypersensitivity or serious adverse effect associated with ketamine treatment
  • 14. Any clinically-significant medication condition or therapy that would preclude treatment with ketamine, to include: Recent myocardial infarction
  • 15. Unstable angina
  • 16. Active neoplasm in the past 6 months
  • 17. Immunosuppressive or corticosteroid therapy within the last month, with the following exceptions: any inhaled, intranasal, topical or vaginal corticosteroids are allowed.
  • 18. Chemotherapy
  • 19. Head injury of loss of consciousness in the past 6 months
  • 20. 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)
  • 21. Systolic blood pressure > 150 and/or diastolic blood pressure >90 at screening
  • 22. A Corrected QT Interval (QTc) > 480 msec as determined by an ECG

Study Details

  • Status
    Completed
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment247 participants
  • Timeline
    Start: 2015-04-20
    End: 2022-12-31
  • Compounds
    KetamineKetamineKetamine
  • Topic
    Suicidality

Locations

University of Alabama at Birmingham — Birmingham, Alabama, United States

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