Clinical trial NCT02655692: CAP-Ketamine for Antidepressant Resistant PTSD
Official title: CAP-Ketamine for Antidepressant Resistant PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: PTSD
Posttraumatic Stress Disorder
Keywords: PTSD
Ketamine
Veteran
Military
Clinical Trial
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: The University of Texas Health Science Center at San Antonio
name: Brooke Army Medical Center
name: Minneapolis Veterans Affairs Medical Center
First posted: 2016-01-14
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: PTSD Checklist (PCL)
timeFrame: Session 1 -Day 0
measure: The PTSD Checklist (PCL)
timeFrame: Session 2 - Day 1
measure: The PTSD Checklist (PCL)
timeFrame: Session 3 - Day 3
measure: The PTSD Checklist (PCL)
timeFrame: Session 4 - Day 7
measure: The PTSD Checklist (PCL)
timeFrame: Session 5 - Day 10
measure: The PTSD Checklist (PCL)
timeFrame: Session 6 - Day 14
measure: The PTSD Checklist (PCL)
timeFrame: Session 7 - Day 17
measure: The PTSD Checklist (PCL)
timeFrame: Session 8 - Day 21
measure: The PTSD Checklist (PCL)
timeFrame: Session 9 - Day 24
measure: The PTSD Checklist (PCL)
timeFrame: Follow-up 1 - Day 25
measure: The PTSD Checklist (PCL)
timeFrame: Follow-up 2 - Day 28
measure: The PTSD Checklist (PCL)
timeFrame: Follow-up 3 - Day 29
measure: The PTSD Checklist (PCL)
timeFrame: Follow-up 4 - Day 35
measure: The PTSD Checklist (PCL)
timeFrame: Follow-up 5 - Day 42
measure: The PTSD Checklist (PCL)
timeFrame: Follow-up 6 - Day 49
measure: The PTSD Checklist (PCL)
timeFrame: Follow-up 7 - Day 56
Secondary outcomes:
measure: Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: Session 1 - Day 0
measure: Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: Session 2 - Day 1
measure: Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: Session 3 - Day 3
measure: Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: Session 4 - Day 7
measure: Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: Session 5 - Day 10
measure: Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: Session 6 - Day 14
measure: Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: Session 7 - Day 17
measure: Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: Session 8 - Day 21
measure: Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: Session 9 - Day 24
measure: Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: Follow-up 1 - Day 25
measure: Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: Follow-up 2 - Day 28
measure: Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: Follow-up 3 - Day 29
measure: Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: Follow-up 4 - Day 35
measure: Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: Follow-up 5 - Day 42
measure: Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: Follow-up 6 - Day 49
measure: Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: Follow-up 7 - Day 56
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
state: Connecticut
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System, Minneapolis, MN
state: Minnesota
city: San Antonio
country: United States
facility: Brooke Army Medical Center
state: Texas
Study officials:
affiliation: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
name: John H. Krystal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.