A pilot randomized placebo-controlled trial of adjunctive aripiprazole for chronic PTSD in US military Veterans resistant to antidepressant treatment

  • Naylor J
  • Kilts J
  • Bradford D
 et al. 
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Abstract

Many individuals with post-traumatic stress disorder (PTSD) experience
persistent symptoms despite pharmacological treatment with
antidepressants. Several open-label monotherapy and adjunctive studies
have suggested that aripiprazole (a second-generation antipsychotic) may
have clinical utility in PTSD. However, there have been no randomized
placebo-controlled trials of aripiprazole use for PTSD. We thus
conducted a pilot randomized controlled trial of adjunctive aripiprazole
versus placebo among Veterans with chronic PTSD serving in the US
military since 11 September 2001 to assess the feasibility, safety,
tolerability, and therapeutic potential of aripiprazole. Sixteen
Veterans were randomized, and 14 completed at least 4 weeks of the
study; 12 completed the entire 8-week trial. Outcome measures included
the Clinician-Administered PTSD Scale (CAPS), PTSD Checklist, Beck
Depression Inventory, Second Edition, and Positive and Negative Syndrome
Scale scores. Aripiprazole was well-tolerated in this cohort, and
improvements in CAPS, PTSD Checklist, Beck Depression Inventory, Second
Edition, and Positive and Negative Syndrome Scale scores were as
hypothesized. Although CAPS change scores did not reach statistical
significance, aripiprazole outperformed placebo by 9 points on the CAPS
in the last observation carried forward analysis compared with the
placebo group (n = 7 per group), and by 20 points in the group
randomized to aripiprazole that completed the entire study (n = 5)
compared with the placebo group (n = 7). Results suggest promise for
aripiprazole as an adjunctive strategy for the treatment of PTSD.
Copyright (C) 2015 Wolters Kluwer Health, Inc. All rights reserved.

Author-supplied keywords

  • Antipsychotic
  • Anxiety
  • Aripiprazole
  • Clinical trial
  • Controlled
  • Depression
  • Post-traumatic stress disorder
  • Psychosis
  • Randomized
  • Veterans

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Authors

  • Jennifer C. Naylor

  • Jason D. Kilts

  • Daniel W. Bradford

  • Jennifer L. Strauss

  • Bruce P. Capehart

  • Steven T. Szabo

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