title: A pilot randomized placebo-controlled trial of adjunctive aripiprazole for chronic PTSD in US military Veterans resistant to antidepressant treatment.
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.
authors: aResearch and Development/Mental Health Services, Durham Veterans Affairs Medical Center bDepartment of Psychiatry and Behavioral Sciences, Duke University Medical Center cVA Mid-Atlantic Mental Illness Research, Education and Clinical Center, Durham Departments of dPsychiatry eBiostatistics, University of North Carolina, Chapel Hill, North Carolina, USA.
authors: Jennifer C
authors: JC
authors: Naylor
authors: Jason D
authors: JD
authors: Kilts
authors: Daniel W
authors: DW
authors: Bradford
authors: Jennifer L
authors: JL
authors: Strauss
authors: Bruce P
authors: BP
authors: Capehart
authors: Steven T
authors: ST
authors: Szabo
authors: Karen D
authors: KD
authors: Smith
authors: Charlotte E
authors: CE
authors: Dunn
authors: Kathryn M
authors: KM
authors: Conner
authors: Jonathan R T
authors: JR
authors: Davidson
authors: Henry Ryan
authors: HR
authors: Wagner
authors: Robert M
authors: RM
authors: Hamer
authors: Christine E
authors: CE
authors: Marx
mesh_terms: D000328:Adult; D000928:Antidepressive Agents / Q000008:administration & dosage*; D014150:Antipsychotic Agents / Q000008:administration & dosage*; D000068180:Aripiprazole / Q000008:administration & dosage*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006787:Hospitals, Veterans; D006801:Humans; D008297:Male; D008875:Middle Aged; D008889:Military Personnel / Q000523:psychology; D010865:Pilot Projects; D013313:Stress Disorders, Post-Traumatic / Q000188:drug therapy* / Q000453:epidemiology / Q000523:psychology*; D016896:Treatment Outcome; D014728:Veterans / Q000523:psychology*; D055815:Young Adult
chemical_list: D000928:Antidepressive Agents; D014150:Antipsychotic Agents; D000068180:Aripiprazole