Naylor Jennifer C, Kilts Jason D, Bradford Daniel W, Strauss Jennifer L, Capehart Bruce P, Szabo Steven T, Smith Karen D, Dunn Charlotte E, Conner Kathryn M, Davidson Jonathan R T, Wagner Henry Ryan, Hamer Robert M, Marx Christine E
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.
Int Clin Psychopharmacol. 2015 May;30(3):167-74. doi: 10.1097/YIC.0000000000000061.
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.
许多患有创伤后应激障碍（PTSD）的个体尽管使用抗抑郁药进行了药物治疗，但仍经历持续的症状。几项开放标签的单一疗法和辅助研究表明，阿立哌唑（一种第二代抗精神病药物）可能对PTSD具有临床效用。然而，尚未有关于阿立哌唑用于PTSD的随机安慰剂对照试验。因此，我们对2001年9月11日以来在美国军队服役的患有慢性PTSD的退伍军人进行了一项阿立哌唑与安慰剂辅助治疗的试点随机对照试验，以评估阿立哌唑的可行性、安全性、耐受性和治疗潜力。16名退伍军人被随机分组，14人完成了至少4周的研究；12人完成了整个8周的试验。结局指标包括临床医生管理的PTSD量表（CAPS）、PTSD检查表、贝克抑郁量表第二版以及阳性和阴性症状量表得分。在该队列中，阿立哌唑耐受性良好，CAPS、PTSD检查表、贝克抑郁量表第二版以及阳性和阴性症状量表得分的改善与假设一致。尽管CAPS变化得分未达到统计学显著性，但在末次观察结转分析中，与安慰剂组（每组n = 7）相比，阿立哌唑在CAPS上比安慰剂组高出9分，在随机分配至阿立哌唑并完成整个研究的组（n = 5）中比安慰剂组（n = 7）高出20分。结果表明阿立哌唑作为PTSD治疗的辅助策略具有前景。
