Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
163 participants
INTERVENTIONAL
2016-04-18
2020-07-01
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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Placebo
Saline dose
Placebo/Saline
This is a saline placebo/non-active solution.
Low Dose Ketamine
Low Dose Ketamine (.20 mg/kg)
Ketamine
FDA approved anesthetic medication with rapid acting antidepressant effects.
High Dose Ketamine
High Dose Ketamine (.50 mg/kg)
Ketamine
FDA approved anesthetic medication with rapid acting antidepressant effects.
Interventions
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Ketamine
FDA approved anesthetic medication with rapid acting antidepressant effects.
Placebo/Saline
This is a saline placebo/non-active solution.
Eligibility Criteria
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Inclusion Criteria
* diagnosis of PTSD
* history of trialing one or more antidepressant medications with little to no PTSD symptom improvement
* ability to provide written informed consent
Exclusion Criteria
* current high risk for suicide
* history of severe head injury
18 Years
70 Years
ALL
No
Sponsors
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The University of Texas Health Science Center at San Antonio
OTHER
Brooke Army Medical Center
FED
Minneapolis Veterans Affairs Medical Center
FED
VA Office of Research and Development
FED
Responsible Party
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Principal Investigators
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John H. Krystal, MD
Role: PRINCIPAL_INVESTIGATOR
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
Locations
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VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, United States
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, United States
Brooke Army Medical Center
San Antonio, Texas, United States
Countries
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References
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Abdallah CG, Roache JD, Averill LA, Young-McCaughan S, Martini B, Gueorguieva R, Amoroso T, Southwick SM, Guthmiller K, Lopez-Roca AL, Lautenschlager K, Mintz J, Litz BT, Williamson DE, Keane TM, Peterson AL, Krystal JH; Consortium to Alleviate PTSD. Repeated ketamine infusions for antidepressant-resistant PTSD: Methods of a multicenter, randomized, placebo-controlled clinical trial. Contemp Clin Trials. 2019 Jun;81:11-18. doi: 10.1016/j.cct.2019.04.009. Epub 2019 Apr 15.
Abdallah CG, Roache JD, Gueorguieva R, Averill LA, Young-McCaughan S, Shiroma PR, Purohit P, Brundige A, Murff W, Ahn KH, Sherif MA, Baltutis EJ, Ranganathan M, D'Souza D, Martini B, Southwick SM, Petrakis IL, Burson RR, Guthmiller KB, Lopez-Roca AL, Lautenschlager KA, McCallin JP 3rd, Hoch MB, Timchenko A, Souza SE, Bryant CE, Mintz J, Litz BT, Williamson DE, Keane TM, Peterson AL, Krystal JH. Dose-related effects of ketamine for antidepressant-resistant symptoms of posttraumatic stress disorder in veterans and active duty military: a double-blind, randomized, placebo-controlled multi-center clinical trial. Neuropsychopharmacology. 2022 Jul;47(8):1574-1581. doi: 10.1038/s41386-022-01266-9. Epub 2022 Jan 19.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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SPLE-003-14W
Identifier Type: -
Identifier Source: org_study_id
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