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An open-label pilot study of aripiprazole for male and female Veterans with chronic post-traumatic stress disorder who respond suboptimally to antidepressants

Youssef, Nagy A.a,b,c; Marx, Christine E.a,b,c; Bradford, Daniel W.b,c; Zinn, Sandrab,c; Hertzberg, Michael A.b,c; Kilts, Jason D.a; Naylor, Jennifer C.a,b,c; Butterfield, Marian I.a,b,c; Strauss, Jennifer L.a,b,c

International Clinical Psychopharmacology:
doi: 10.1097/YIC.0b013e328352ef4e
Original Articles
Abstract

Emerging data suggest that second-generation antipsychotics such as aripiprazole may be effective in the treatment of post-traumatic stress disorder (PTSD). However, few clinical trials have used aripiprazole in PTSD, and data are limited on its use in Veterans with PTSD. The objective of this pilot trial was to investigate the safety and efficacy of aripiprazole in Veterans with PTSD. Ten individuals (five men and five women) meeting the Diagnostic and statistical manual of mental disorders, 4th ed., PTSD criteria participated in this 12-week, open-label, flexibly dosed monotherapy trial. The dose range of aripiprazole was 5–30 mg/day, titrated to tolerability and clinical response. The primary outcome measure was the Clinician-Administered PTSD Scale. Additional outcomes included the Short PTSD Rating Interview, the Treatment Outcome PTSD Scale (Top-8), the Davidson Trauma Scale, the Positive and Negative Syndrome Scale, the Beck Depression Inventory-Fast Screen, and Clinical Global Impressions-Improvement. Eight participants completed the study, and aripiprazole was generally well tolerated and associated with a significant improvement in PTSD symptoms, as measured by the Clinician-Administered PTSD Scale (primary outcome measure) and by the Short PTSD Rating Interview, the Treatment Outcome PTSD Scale, and the Davidson Trauma Scale. An improvement was also observed on all three Positive and Negative Syndrome Scale subscales and the Beck Depression Inventory-Fast Screen, and the average Clinical Global Impressions-Improvement ratings indicated that patients were ‘much improved’. These promising initial results merit further investigation in a larger, randomized-controlled trial.

Author Information

aVA Mid-Atlantic Mental Illness, Research and Clinical Center (MIRECC)

bDurham Veterans Affairs Medical Center

cDepartment of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina, USA

A poster abstract presenting these findings in part was presented at the American Psychiatric Association Annual Meeting; Toronto, Canada, May 2006.

Correspondence to Jennifer L. Strauss, PhD, Durham VA Medical Center, VISN 6 MIRECC, Bldg 6, 508 Fulton Street, Durham, NC 27705, USA Tel: +1 919 286 0411 x5275; fax: +1 919 286 6811; e-mail: jennifer.strauss@duke.edu

Received August 17, 2011

Accepted February 23, 2012

© 2012 Lippincott Williams & Wilkins, Inc.