CAP-Ketamine for Antidepressant Resistant PTSD

• ClinicalTrials.gov Identifier: NCT02655692
• Recruitment Status: Completed
• First Posted: January 14, 2016
• Last Update Posted: July 15, 2020
• 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

• First Submitted Date: January 7, 2016
• First Posted Date: January 14, 2016
• Last Update Posted Date: July 15, 2020
• Actual Study Start Date: April 18, 2016
• Actual Primary Completion Date: July 1, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: CAP-Ketamine for Antidepressant Resistant PTSD
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• PTSD
• Posttraumatic Stress Disorder

Intervention

• Drug: Ketamine
  FDA approved anesthetic medication with rapid acting antidepressant effects.
• Drug: Placebo
  This is a saline placebo/non-active solution.

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 14, 2020): 168
• Original Estimated Enrollment (submitted: January 11, 2016): 198
• Actual Study Completion Date: July 1, 2020
• Actual Primary Completion Date: July 1, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02655692
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: VA Office of Research and Development
• Study 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

Investigators

• 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