TY - JOUR
T1 - Repeated ketamine infusions for antidepressant-resistant PTSD
T2 - Methods of a multicenter, randomized, placebo-controlled clinical trial
AU - for the Consortium to Alleviate PTSD
AU - Abdallah, Chadi G.
AU - Roache, John D.
AU - Averill, Lynnette A.
AU - Young-McCaughan, Stacey
AU - Martini, Brenda
AU - Gueorguieva, Ralitza
AU - Amoroso, Timothy
AU - Southwick, Steven M.
AU - Guthmiller, Kevin
AU - López-Roca, Argelio L.
AU - Lautenschlager, Karl
AU - Mintz, Jim
AU - Litz, Brett T.
AU - Williamson, Douglas E.
AU - Keane, Terence M.
AU - Peterson, Alan L.
AU - Krystal, John H.
N1 - Funding Information:
This research was supported by Consortium to Alleviate PTSD (CAP) award numbers W81XWH-13-2-0065 from the U.S. Department of Defense , Defense Health Program, Psychological Health and Traumatic Brain Injury Research Program (PH/TBI RP), and I01CX001136–01 from the U.S. Department of Veterans Affairs , Office of Research & Development , Clinical Science Research & Development Service. Additional support funding was provided by the VA National Center for PTSD.
Publisher Copyright:
© 2019
PY - 2019/6
Y1 - 2019/6
N2 - Posttraumatic stress disorder (PTSD) is a debilitating disorder with limited medication treatment options. Recent reports have described the dearth of research on new drug development as a crisis in the pharmacotherapy of PTSD. There are only two PTSD medications approved by the U.S. Food and Drug Administration, and both are serotonergic antidepressants. Therefore, there is a tremendous need to identify more effective and more rapidly acting pharmacotherapies for PTSD that work through novel neural mechanisms. Pilot evidence and case reports provided preliminary evidence supporting the safety and utility of investigating the therapeutic effects of ketamine in PTSD. However, the efficacy of this drug for PTSD has not yet been tested in active duty military or veteran populations. Here, we report the design and methods of a study funded under the Consortium to Alleviate PTSD. The study is a multisite, placebo-controlled, double–blind, randomized clinical trial to examine the dose-related efficacy of ketamine, as compared to placebo, in producing a rapid and sustained reduction in PTSD symptomatology in veterans and active duty military populations with antidepressant-resistant PTSD. Approximately 198 eligible participants who meet criteria for PTSD will be randomized to the study drug (i.e., ketamine 0.5 mg/kg, ketamine 0.2 mg/kg, or placebo). The study drug will be administered intravenously twice per week for 4 weeks, followed by a 4-week follow-up period. This ongoing study is the only trial of therapeutic effects of ketamine for PTSD and the first placebo-controlled trial to determine the dose-related effects of repeated ketamine on PTSD.
AB - Posttraumatic stress disorder (PTSD) is a debilitating disorder with limited medication treatment options. Recent reports have described the dearth of research on new drug development as a crisis in the pharmacotherapy of PTSD. There are only two PTSD medications approved by the U.S. Food and Drug Administration, and both are serotonergic antidepressants. Therefore, there is a tremendous need to identify more effective and more rapidly acting pharmacotherapies for PTSD that work through novel neural mechanisms. Pilot evidence and case reports provided preliminary evidence supporting the safety and utility of investigating the therapeutic effects of ketamine in PTSD. However, the efficacy of this drug for PTSD has not yet been tested in active duty military or veteran populations. Here, we report the design and methods of a study funded under the Consortium to Alleviate PTSD. The study is a multisite, placebo-controlled, double–blind, randomized clinical trial to examine the dose-related efficacy of ketamine, as compared to placebo, in producing a rapid and sustained reduction in PTSD symptomatology in veterans and active duty military populations with antidepressant-resistant PTSD. Approximately 198 eligible participants who meet criteria for PTSD will be randomized to the study drug (i.e., ketamine 0.5 mg/kg, ketamine 0.2 mg/kg, or placebo). The study drug will be administered intravenously twice per week for 4 weeks, followed by a 4-week follow-up period. This ongoing study is the only trial of therapeutic effects of ketamine for PTSD and the first placebo-controlled trial to determine the dose-related effects of repeated ketamine on PTSD.
KW - Active duty military
KW - Combat
KW - Ketamine
KW - PTSD
KW - Rapid-acting antidepressant
KW - Treatment resistant
KW - Veterans
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U2 - 10.1016/j.cct.2019.04.009
DO - 10.1016/j.cct.2019.04.009
M3 - Article
C2 - 30999057
AN - SCOPUS:85064313070
SN - 1551-7144
VL - 81
SP - 11
EP - 18
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
ER -