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

• Status: Active, not recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to examine whether neural-derived exosomal miRNAs are differentially expressed that are specific to suicidal ideation or behavior, and which by affecting specific miRNA targets and pathways, are associated with suicidal behavior and response to ketamine. The following groups of subjects will be examined: 1) major depressive disorder (MDD) with a recent suicide attempt (in past 2 weeks), 2) MDD with serious ideation (in the past 7 days) without recent suicide attempt (in the past 6 months), 3) MDD without clinically significant suicidal ideation (in the past 7 days) or recent suicide attempt (in the past 6 months), and 4) healthy controls. Both suicidal and non-suicidal MDD will be given ketamine (0.5 mg/kg, IV) and blood will be drawn at predose, 30 min, 180 min, 24 hours, and 14 days post-infusion to measure changes in miRNAs.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Alabama at Birmingham
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Ketamine

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 MDE as determined by the MINI (MDD participants)

5. 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, 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:

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-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 QTc > 480 msec as determined by an ECG