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A Randomized Controlled Trial of Repeated Ketamine Administration for Chronic Posttraumatic Stress Disorder.
- Source :
-
The American journal of psychiatry [Am J Psychiatry] 2021 Feb 01; Vol. 178 (2), pp. 193-202. Date of Electronic Publication: 2021 Jan 05. - Publication Year :
- 2021
-
Abstract
- Objective: Posttraumatic stress disorder (PTSD) is a chronic and disabling disorder, for which available pharmacotherapies have limited efficacy. The authors' previous proof-of-concept randomized controlled trial of single-dose intravenous ketamine infusion in individuals with PTSD showed significant and rapid PTSD symptom reduction 24 hours postinfusion. The present study is the first randomized controlled trial to test the efficacy and safety of repeated intravenous ketamine infusions for the treatment of chronic PTSD.<br />Methods: Individuals with chronic PTSD (N=30) were randomly assigned (1:1) to receive six infusions of ketamine (0.5 mg/kg) or midazolam (0.045 mg/kg) (psychoactive placebo control) over 2 consecutive weeks. Clinician-rated and self-report assessments were administered 24 hours after the first infusion and at weekly visits. The primary outcome measure was change in PTSD symptom severity, as assessed with the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), from baseline to 2 weeks (after completion of all infusions). Secondary outcome measures included the Impact of Event Scale-Revised, the Montgomery-Åsberg Depression Rating Scale (MADRS), and side effect measures.<br />Results: The ketamine group showed a significantly greater improvement in CAPS-5 and MADRS total scores than the midazolam group from baseline to week 2. At week 2, the mean CAPS-5 total score was 11.88 points (SE=3.96) lower in the ketamine group than in the midazolam group (d=1.13, 95% CI=0.36, 1.91). Sixty-seven percent of participants in the ketamine group were treatment responders, compared with 20% in the midazolam group. Among ketamine responders, the median time to loss of response was 27.5 days following the 2-week course of infusions. Ketamine infusions were well tolerated overall, without serious adverse events.<br />Conclusions: This randomized controlled trial provides the first evidence of efficacy of repeated ketamine infusions in reducing symptom severity in individuals with chronic PTSD. Further studies are warranted to understand ketamine's full potential as a treatment for chronic PTSD.
- Subjects :
- Adolescent
Adult
Aged
Chronic Disease
Double-Blind Method
Female
Humans
Ketamine administration & dosage
Male
Middle Aged
Receptors, N-Methyl-D-Aspartate antagonists & inhibitors
Stress Disorders, Post-Traumatic complications
Stress Disorders, Post-Traumatic psychology
Treatment Outcome
Young Adult
Antidepressive Agents therapeutic use
Depression drug therapy
Ketamine therapeutic use
Stress Disorders, Post-Traumatic drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1535-7228
- Volume :
- 178
- Issue :
- 2
- Database :
- MEDLINE
- Journal :
- The American journal of psychiatry
- Publication Type :
- Academic Journal
- Accession number :
- 33397139
- Full Text :
- https://doi.org/10.1176/appi.ajp.2020.20050596