Ketamine as a Treatment for Post-Traumatic Stress Disorder (PTSD)
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ClinicalTrials.gov Identifier: NCT02397889 |
Recruitment Status :
Completed
First Posted : March 25, 2015
Results First Posted : February 11, 2021
Last Update Posted : March 11, 2021
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Tracking Information | ||||
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First Submitted Date ICMJE | March 19, 2015 | |||
First Posted Date ICMJE | March 25, 2015 | |||
Results First Submitted Date ICMJE | January 25, 2021 | |||
Results First Posted Date ICMJE | February 11, 2021 | |||
Last Update Posted Date | March 11, 2021 | |||
Study Start Date ICMJE | May 18, 2015 | |||
Actual Primary Completion Date | January 27, 2020 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) [ Time Frame: 2 weeks after the first infusion ] full range score from 0-80, with higher scores indicating greater PTSD symptoms
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Original Primary Outcome Measures ICMJE |
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Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Ketamine as a Treatment for Post-Traumatic Stress Disorder (PTSD) | |||
Official Title ICMJE | Randomized Controlled Trial of Repeated-Dose Intravenous Ketamine for PTSD | |||
Brief Summary | The purpose of this study is to study new ways to treat post-traumatic stress disorder (PTSD). Current treatments for PTSD do not work for everyone and it can take time to determine whether a person responds to a chosen treatment. The purpose of this study is to see whether ketamine, when given repeatedly intravenously can produce a quick and persistent improvement in PTSD symptoms. At higher doses, ketamine has been used for many years as an anesthetic for medical procedures, and at lower doses may be an effective treatment in patients with major depression and PTSD. Ketamine given for PTSD is investigational, which means that the FDA has not yet approved the drug for treating this condition. In this study, the effects of ketamine will be compared to those of midazolam. Midazolam has similar acute anesthetic effects compared to ketamine but has not been shown to treat or alleviate any symptoms of PTSD. This makes midazolam an appropriate substance to gauge whether ketamine can treat or alleviate PTSD symptoms thereby acting as what we call an active control. | |||
Detailed Description | Ketamine is an approved medication in several countries for the induction of general anesthesia and for use as adjunct to other anesthetics. Intravenous ketamine is being developed and tested for the treatment of posttraumatic stress disorder (PTSD). All subjects will be administered the study medication by the study anesthesiologists and under the direct supervision of the investigator or designee. On all dosing days, all subjects must remain at the clinical site until at least 4 hours post-dose (or longer if required for study procedures) and will be accompanied by a responsible adult when discharged from the clinical site. The end of study will occur when the last subject in the trial completes his/her last study assessment. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 Phase 3 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Posttraumatic Stress Disorder (PTSD) | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Feder A, Costi S, Rutter SB, Collins AB, Govindarajulu U, Jha MK, Horn SR, Kautz M, Corniquel M, Collins KA, Bevilacqua L, Glasgow AM, Brallier J, Pietrzak RH, Murrough JW, Charney DS. A Randomized Controlled Trial of Repeated Ketamine Administration for Chronic Posttraumatic Stress Disorder. Am J Psychiatry. 2021 Feb 1;178(2):193-202. doi: 10.1176/appi.ajp.2020.20050596. Epub 2021 Jan 5. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
30 | |||
Original Estimated Enrollment ICMJE |
40 | |||
Actual Study Completion Date ICMJE | January 27, 2020 | |||
Actual Primary Completion Date | January 27, 2020 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02397889 | |||
Other Study ID Numbers ICMJE | GCO 15-0265 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE |
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Current Responsible Party | Adriana Feder, Icahn School of Medicine at Mount Sinai | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | Icahn School of Medicine at Mount Sinai | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Icahn School of Medicine at Mount Sinai | |||
Verification Date | February 2021 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |