Double-blind randomized controlled study of the efficacy, safety and tolerability of eszopiclone vs placebo for the treatment of patients with post-traumatic stress disorder and insomnia  

作　　者：Sheila M Dowd Alyson K Zalta Helen J Burgess Elizabeth C Adkins Zerbrina Valdespino-Hayden Mark H Pollack 

机构地区：[1]Department of Psychiatry and Behavioral Sciences,Rush University Medical Center,Chicago,IL 60601,United States [2]Department of Psychological Science,University of California Irvine,Irvine,CA 92697,United States [3]Sleep and Circadian Research Laboratory,Department of Psychiatry,University of Michigan,Ann Arbor,MI 48109,United States [4]Center for Behavioral Intervention Technologies|Department of Preventive Medicine,Northwestern University Feinberg School of Medicine,Chicago,IL 60611,United States [5]Department of Psychology,Montclair State University,Montclair,NJ 07043,United States

出　　处：《World Journal of Psychiatry》2020年第3期21-28,共8页世界精神病学杂志

基　　金：Supported by National Institute of Mental Health,No.5R34MH91338-03 and No.K23 MH103394(to Zalta AK)

摘　　要：BACKGROUND Sleep disturbance is a core feature of post-traumatic stress disorder(PTSD).Given the relationship between sleep disturbance and PTSD,there has been a relative paucity of studies examining the potential therapeutic impact of using pharmacotherapy to target sleep disturbance in patients with PTSD.Eszopiclone(ESZ)is a non-benzodiazepine y-aminobutyric acid-A receptor agonist indicated for the treatment of sleep and may affect sleep in patients with PTSD.AIM To evaluate the efficacy of ESZ vs placebo(PBO)for patients with PTSD and insomnia.METHODS The study was a 12-wk,double blind,randomized controlled trial with 3 mg of ESZ(n=13)or PBO(n=12).RESULTS Patients in both arms experienced significant improvement in PTSD symptoms as assessed by the Clinician-Administered PTSD Scale for DSM-IV(CAPS):ESZ(t11=-3.12,P=0.005)and PBO(t11=-3.5,P=0.002)and by self-report with the Short PTSD Rating Interview(ESZ t11=-3.38,P=0.003 and PBO t11=-4.48,P=0.0005).There were no significant differences between treatments on the CAPS(t22=-0.13,P=0.70)or the Short PTSD Rating Interview(t22=-0.58,P=0.56).Similarly,both treated groups improved on sleep measures as assessed by the Pittsburgh Sleep Quality Index with PTSD Addendum(PSQI)and on total sleep time(TST)and sleep latency assessed by actigraphy with no significant differences between groups(PSQI t22=-0.24,P=0.81;total sleep time t10=0.13,P=0.90 and sleep latency t10=0.68,P=0.50).There was a significant correlation between improvement in sleep and overall improvement in PTSD as measured by change scores on the PSQI and CAPS,r(8)=0.79,P=0.01 for ESZ treated subjects,but not for those treated with PBO r(9)=0.16,P=0.69.Adverse events of ESZ were consistent with the known profile of the medication including dysgeusia(30%,mild),sedation(20%,mild)and headache(20%,moderate to severe).CONCLUSION Results do not support the hypothesis of a specific positive effect of ESZ compared to PBO for measures of PTSD and associated sleep disturbance.BACKGROUND Sleep disturbance is a core feature of post-traumatic stress disorder(PTSD).Given the relationship between sleep disturbance and PTSD, there has been a relative paucity of studies examining the potential therapeutic impact of using pharmacotherapy to target sleep disturbance in patients with PTSD. Eszopiclone(ESZ) is a non-benzodiazepine y-aminobutyric acid-A receptor agonist indicated for the treatment of sleep and may affect sleep in patients with PTSD.AIM To evaluate the efficacy of ESZ vs placebo(PBO) for patients with PTSD and insomnia.METHODS The study was a 12-wk, double blind, randomized controlled trial with 3 mg of ESZ(n = 13) or PBO(n = 12).RESULTS Patients in both arms experienced significant improvement in PTSD symptoms as assessed by the Clinician-Administered PTSD Scale for DSM-IV(CAPS): ESZ(t11=-3.12, P = 0.005) and PBO(t11 =-3.5, P = 0.002) and by self-report with the Short PTSD Rating Interview(ESZ t11 =-3.38, P = 0.003 and PBO t11 =-4.48, P =0.0005). There were no significant differences between treatments on the CAPS(t22 =-0.13, P = 0.70) or the Short PTSD Rating Interview(t22 =-0.58, P = 0.56).Similarly, both treated groups improved on sleep measures as assessed by the Pittsburgh Sleep Quality Index with PTSD Addendum(PSQI) and on total sleep time(TST) and sleep latency assessed by actigraphy with no significant differences between groups(PSQI t22 =-0.24, P = 0.81; total sleep time t10 = 0.13,P = 0.90 and sleep latency t10 = 0.68, P = 0.50). There was a significant correlation between improvement in sleep and overall improvement in PTSD as measured by change scores on the PSQI and CAPS, r(8) = 0.79, P = 0.01 for ESZ treated subjects, but not for those treated with PBO r(9) = 0.16, P = 0.69. Adverse events of ESZ were consistent with the known profile of the medication including dysgeusia(30%, mild), sedation(20%, mild) and headache(20%, moderate to severe).CONCLUSION Results do not support the hypothesis of a specific positive effect of ESZ compared to PBO for measures of PTSD and

关 键 词：TRAUMA Sleep disturbance HYPNOTIC Post-traumatic stress disorder 

分 类 号：R749.5[医药卫生—神经病学与精神病学]