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History of Changes for Study: NCT02418195
Plasma Exosomal MicroRNAs as Promising Novel Biomarkers for Suicidality and Treatment Outcome
Latest version (submitted July 5, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 15, 2015 None (earliest Version on record)
2 April 16, 2015 Study Description, Eligibility, Arms and Interventions, Conditions, Study Status and Study Identification
3 June 18, 2015 Contacts/Locations and Study Status
4 February 5, 2016 Sponsor/Collaborators and Study Status
5 October 25, 2016 Contacts/Locations, Sponsor/Collaborators, Eligibility and Study Status
6 October 31, 2017 Contacts/Locations and Study Status
7 August 2, 2018 Contacts/Locations, Study Status and Eligibility
8 June 12, 2019 Study Status
9 January 30, 2020 Study Status and Study Design
10 June 23, 2020 Study Status
11 January 20, 2021 Recruitment Status, Study Status, Contacts/Locations and Study Design
12 June 30, 2021 Study Status
13 October 18, 2021 Study Status
14 February 1, 2022 Study Status
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Results Submission Events
15 June 7, 2022 Recruitment Status, Study Status, Outcome Measures, Study Description, Document Section, Results, Eligibility and Arms and Interventions
16 July 5, 2022 Study Status and Study Description
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Study NCT02418195
Submitted Date:  April 15, 2015 (v1)

Open or close this module Study Identification
Unique Protocol ID: F141029007
Brief Title: Plasma Exosomal MicroRNAs as Promising Novel Biomarkers for Suicidality and Treatment Outcome
Official Title: Plasma Exosomal MicroRNAs as Promising Novel Biomarkers for Suicidality and Treatment Outcome
Secondary IDs: 1R01MH107183-01 [U.S. NIH Grant/Contract]
Open or close this module Study Status
Record Verification: April 2015
Overall Status: Recruiting
Study Start: April 2015
Primary Completion: April 2020 [Anticipated]
Study Completion: April 2020 [Anticipated]
First Submitted: April 13, 2015
First Submitted that
Met QC Criteria:
April 15, 2015
First Posted: April 16, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
April 15, 2015
Last Update Posted: April 16, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: University of Alabama at Birmingham
Responsible Party: Principal Investigator
Investigator: Yogesh Dwivedi, PhD
Official Title: Professor
Affiliation: University of Alabama at Birmingham
Collaborators: National Institute of Mental Health (NIMH)
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief 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 without recent suicide attempt (in the past 6 months), 3) MDD without clinically significant suicidal ideation or 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 drawn at predose, 30 min, 180 min, 24 hours, and 14 days post-infusion to measure changes in miRNAs.
Detailed Description:

Neural miRNAs are responsive to environmental, synaptic, and pathological changes and can be actively secreted by cells such as exosomes from brain into blood. These exosomes bear cell-type specific surface markers. Using a neural specific surface marker, the investigators successfully isolated neural-derived exosomes and found that these exosomes are enriched with miRNAs/mRNAs that are expressed in brain. Using this novel approach the investigators aim to examine whether neural derived exosomal miRNAs are differentially expressed that are specific to suicidal ideation or behavior, and which by affecting specific mRNA 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 without recent suicide attempt (in the past 6 months), 3) MDD without clinically significant suicidal ideation or 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 drawn at 30 and 180 min post-infusion to measure changes in miRNAs. The investigators also propose a parallel human postmortem brain study to examine whether changes in miRNAs in suicidality correspond to miRNA changes in brain by comparing dlPFC and hippocampus from MDD suicide, MDD non-suicide, and control subjects.

With this the investigators attempt to discover 1) whether suicidal ideation or behavior is associated with differences in the expression of specific miRNAs, 2) whether anti-suicidal/antidepressant effects of ketamine is associated with miRNAs changes, and 3) whether miRNA/mRNA-regulatory pathways contribute to suicide pathogenesis and treatment response. Our study will provide a novel avenue for the development of miRNAs as ''molecular tool'' to identify suicidality and treatment response and in generating target based therapies to treat this devastating disorder.

Open or close this module Conditions
Conditions: Major Depressive Disorder
Keywords: Depression
Suicidality
Suicide Attempt
Suicidal Ideation
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Basic Science
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 4
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 240 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: MDD with recent Suicide Attempt
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 0.5mg/kg at a rate of 40mL over 40 minutes. Blood will be drawn at pre-dose, 30minutes post dose, 180 minutes post dose, 24 hours post dose, and 14 days post dose to measure changes in miRNAs.
Drug: ketamine
IV infusion of ketamine 0.5mg/kg at a rate of 40mL over 40 minutes
Other Names:
  • ketalar
Active Comparator: MDD with Suicidal Ideation no attempt
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 0.5mg/kg at a rate of 40mL over 40 minutes. Blood will be drawn at pre-dose, 30minutes post dose, 180 minutes post dose, 24 hours post dose, and 14 days post dose to measure changes in miRNAs.
Drug: ketamine
IV infusion of ketamine 0.5mg/kg at a rate of 40mL over 40 minutes
Other Names:
  • ketalar
Active Comparator: MDD without Suicidal Ideation no attempt
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 0.5mg/kg at a rate of 40mL over 40 minutes. Blood will be drawn at pre-dose, 30minutes post dose, 180 minutes post dose, 24 hours post dose, and 14 days post dose to measure changes in miRNAs.
Drug: ketamine
IV infusion of ketamine 0.5mg/kg at a rate of 40mL over 40 minutes
Other Names:
  • ketalar
No Intervention: Healthy Controls
Healthy Control subjects without a psychiatric diagnosis will have a one-time blood draw to examine miRNAs.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Beck Scale for Suicide Ideation (BSS)
[ Time Frame: 180 minutes post dose ]

Secondary Outcome Measures:
1. Montgomery Asberg Depression Rating Scale (MADRS)
[ Time Frame: 180 minutes post dose ]

2. Beck Depression Inventory (BDI)
[ Time Frame: 180 minutes post dose ]

3. Beck Anxiety Inventory (BAI)
[ Time Frame: 180 minutes post dose ]

4. Beck Hopelessness Scale (BHS)
[ Time Frame: 180 minutes post dose ]

5. 4-item Brief Psychiatric Rating Scale (BPRS)
[ Time Frame: 180 minutes post dose ]

6. Clinician-Administered Dissociative States Scale (CADSS)
[ Time Frame: 180 minutes post dose ]

7. Young Mania Rating Scale (YMRS)
[ Time Frame: 180 minutes post dose ]

8. Systematic Assessment for Treatment Emergent Events (SAFTEE)
[ Time Frame: 180 minutes post dose ]

Open or close this module Eligibility
Minimum Age: 19 Years
Maximum Age: 65 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

  1. Age 19-65
  2. Physically healthy and capable of undergoing ketamine infusion
  3. Willing and able to provide informed consent

    MDD participants:

  4. Diagnosis of MDE as determined by the MINI
  5. HAM-D 21 score ≥ 16

    MDD Participants with Suicide Attempt:

  6. Suicide attempt occurred within past 2 weeks
  7. For the time frame of the past 7 days, C-SSRS score ≥ 3 MDD Participants without Suicide Attempt without SI
  8. For the time frame of the past 7 days, C-SSRS score < 3

Exclusion Criteria:

  1. Pregnancy or lactation (women of reproductive potential must have a negative urine pregnancy screen)
  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 any medication known to affect the glutamate-NMDA receptor system (e.g., 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
  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 (other hepatitis is OK if stable)
    • Autoimmune peripheral neuropathy (other peripheral neuropathy is OK)
    • Autoimmune pancreatitis (history of alcoholic pancreatitis is OK if resolved)
    • Behcet's disease
    • Chrohn's disease (IBS is OK)
    • 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
    • (HIV and Hepatitis are OK if stable)
Open or close this module Contacts/Locations
Central Contact Person: Emily H Bruer, M.Ed.
Telephone: 205-975-2911
Email: ebruer@uab.edu
Central Contact Backup: Hollis Ryan, B.S.
Telephone: 205-975-0068
Email: heryan@uab.edu
Study Officials: Yogesh Dwivedi, Ph.D.
Principal Investigator
University of Alabama at Birmingham
Richard C Shelton, M.D.
Principal Investigator
University of Alabama at Birmingham
Locations: United States, Alabama
University of Alabama at Birmingham
[Recruiting]
Birmingham, Alabama, United States, 35294
Contact:Contact: Emily H Bruer, MEd 205-975-2911 ebruer@uab.edu
Contact:Contact: Hollis R Ryan, BS 205-975-0068 heryan@uab.edu
Contact:Principal Investigator: Yogesh Dwivedi, PhD
Contact:Principal Investigator: Richard C Shelton, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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