Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
75 participants
INTERVENTIONAL
2021-03-09
2025-10-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ketamine and prolonged exposure (PE)
Single IV ketamine 0.5 mg/kg 24-72 hrs prior to PE session at week 1,2, and 3 followed by 7 additional PE sessions.
Ketamine
FDA approved anesthetic medication with rapid acting antidepressant effects.
Midazolam and prolonged exposure (PE)
Single IV midazolam 0.045 mg/kg 24-72 hrs prior to PE session at week 1,2, and 3 followed by 7 additional PE sessions.
Midazolam
FDA approved sedative medication with dissociative effects.
Interventions
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Ketamine
FDA approved anesthetic medication with rapid acting antidepressant effects.
Midazolam
FDA approved sedative medication with dissociative effects.
Eligibility Criteria
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Inclusion Criteria
* diagnosis of PTSD
* ability to provide written informed consent
Exclusion Criteria
* current high risk for suicide
* history of moderate/severe head injury
* history of psychosis
* current episode of mania/hypomania
* severe substance and/or alcohol use disorder in the last 6 months
18 Years
75 Years
ALL
No
Sponsors
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VA Office of Research and Development
FED
Responsible Party
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Principal Investigators
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Paulo R Shiroma, MD
Role: PRINCIPAL_INVESTIGATOR
Minneapolis VA Health Care System, Minneapolis, MN
Locations
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Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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MHBP-006-19F
Identifier Type: -
Identifier Source: org_study_id
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