CAP-Ketamine for Antidepressant Resistant PTSD
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02655692 |
Recruitment Status :
Completed
First Posted : January 14, 2016
Last Update Posted : July 15, 2020
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Sponsor:
VA Office of Research and Development
Collaborators:
The University of Texas Health Science Center at San Antonio
Brooke Army Medical Center
Minneapolis Veterans Affairs Medical Center
Information provided by (Responsible Party):
VA Office of Research and Development
Tracking Information | |||||
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First Submitted Date ICMJE | January 7, 2016 | ||||
First Posted Date ICMJE | January 14, 2016 | ||||
Last Update Posted Date | July 15, 2020 | ||||
Actual Study Start Date ICMJE | April 18, 2016 | ||||
Actual Primary Completion Date | July 1, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
PTSD Checklist to measure change in PTSD symptoms from baseline to post-treatment (4 weeks) [ Time Frame: 24-hours post-infusions; weekly for 4 weeks following last infusion ] The PTSD Checklist (PCL) is a brief measure of the symptoms of Posttraumatic Stress Disorder. Item and total scores will be recorded and aggregated from all study participants.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | CAP-Ketamine for Antidepressant Resistant PTSD | ||||
Official Title ICMJE | CAP-Ketamine for Antidepressant Resistant PTSD | ||||
Brief Summary | The purpose of this study is to test the safety and efficacy of repeated doses of ketamine as compared to placebo, in reducing symptoms of Posttraumatic Stress Disorder (PTSD) in an active duty military and Veteran population. | ||||
Detailed Description | In this 2-site clinical trial, intended to evaluate the safety and efficacy of repeated doses of ketamine for treatment resistant PTSD, Veterans and active duty military personnel who meet criteria for PTSD and the additional inclusion and exclusion criteria will be randomized to one of three treatment arms (placebo, low dose ketamine, high dose ketamine). Participants receive the study drug via intravenous infusion twice per week for 4-weeks. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* 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 |
168 | ||||
Original Estimated Enrollment ICMJE |
198 | ||||
Actual Study Completion Date ICMJE | July 1, 2020 | ||||
Actual Primary Completion Date | July 1, 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 70 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 | NCT02655692 | ||||
Other Study ID Numbers ICMJE | SPLE-003-14W | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | VA Office of Research and Development | ||||
Study Sponsor ICMJE | VA Office of Research and Development | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | VA Office of Research and Development | ||||
Verification Date | July 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |