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CAP-Ketamine for Antidepressant Resistant PTSD

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
Sponsor:
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
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
 (submitted: January 11, 2016)
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.
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
Condition  ICMJE
  • PTSD
  • Posttraumatic Stress Disorder
Intervention  ICMJE
  • Drug: Ketamine
    FDA approved anesthetic medication with rapid acting antidepressant effects.
  • Drug: Placebo
    This is a saline placebo/non-active solution.
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Saline dose
    Intervention: Drug: Placebo
  • Experimental: Low Dose Ketamine
    Low Dose Ketamine (.20 mg/kg)
    Intervention: Drug: Ketamine
  • Experimental: High Dose Ketamine
    High Dose Ketamine (.50 mg/kg)
    Intervention: Drug: Ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 14, 2020)
168
Original Estimated Enrollment  ICMJE
 (submitted: January 11, 2016)
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:

  • male or female Veterans or active duty military personnel between the ages of 18 and 70 years
  • 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:

  • females who are currently pregnant or breastfeeding
  • current high risk for suicide
  • history of severe head injury
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE
  • The University of Texas Health Science Center at San Antonio
  • Brooke Army Medical Center
  • Minneapolis Veterans Affairs Medical Center
Investigators  ICMJE
Principal Investigator: John H. Krystal, MD VA Connecticut Healthcare System West Haven Campus, West Haven, CT
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