Ramaswamy Sriram, Driscoll David, Smith Lynette M, Bhatia Subhash C, Petty Frederick
Department of Psychiatry, Creighton University School of Medicine, Omaha, NE, USA.
Nebraska Western Iowa VA Healthcare System, Omaha, NE, USA.
Contemp Clin Trials Commun. 2015 Dec 18;2:1-5. doi: 10.1016/j.conctc.2015.12.003. eCollection 2016 Apr 15.
Post-traumatic stress disorder (PTSD) is a chronic anxiety disorder that is often difficult to treat. Patients suffering from PTSD often fail to respond to antidepressants and may have a high incidence of positive symptoms of psychosis, though antipsychotic medications have been minimally studied in this population. The aim of this study was to assess the impact of the atypical antipsychotic ziprasidone (Geodon) on PTSD symptom clusters, as well as comorbid major depressive disorder. To our knowledge, this is the first completed randomized controlled trial investigating the potential efficacy and tolerability of ziprasidone in patients with chronic PTSD.
We conducted a 9-week prospective, randomized, double-blind, placebo-controlled trial of ziprasidone in 30 patients diagnosed with PTSD and comorbid depression. After screening and randomization, patients completed nine weekly study visits at which treatment safety and efficacy were evaluated. Primary measures of efficacy included total and subscale scores from the Clinician-Administered PTSD Scale (CAPS), while the Hamilton Rating Scale for Depression (HAM-D), Hamilton Anxiety Scale (HAM-A), Clinical Global Impression (CGI), and Treatment Outcome PTSD Scale (TOP-8) were implemented as secondary efficacy measures.
We observed no significant effect of treatment on reduction of PTSD or depression symptoms from pre- to post-treatment.
Our findings suggest that ziprasidone treatment may not significantly improve symptoms of PTSD or comorbid depression, though further study is needed.
创伤后应激障碍(PTSD)是一种慢性焦虑症,通常难以治疗。患有创伤后应激障碍的患者往往对抗抑郁药无反应,并且可能有较高的精神病阳性症状发生率,尽管抗精神病药物在该人群中的研究很少。本研究的目的是评估非典型抗精神病药物齐拉西酮(Geodon)对创伤后应激障碍症状群以及共病的重度抑郁症的影响。据我们所知,这是第一项完成的随机对照试验,研究齐拉西酮在慢性创伤后应激障碍患者中的潜在疗效和耐受性。
我们对30名诊断为创伤后应激障碍和共病抑郁症的患者进行了为期9周的前瞻性、随机、双盲、安慰剂对照的齐拉西酮试验。经过筛选和随机分组后,患者完成了九次每周一次的研究访视,在访视中评估治疗的安全性和疗效。主要疗效指标包括临床医生评定的创伤后应激障碍量表(CAPS)的总分和分量表得分,而汉密尔顿抑郁量表(HAM-D)、汉密尔顿焦虑量表(HAM-A)、临床总体印象(CGI)和创伤后应激障碍治疗结果量表(TOP-8)作为次要疗效指标。
我们观察到治疗前后创伤后应激障碍或抑郁症状的减轻没有显著效果。
我们的研究结果表明,齐拉西酮治疗可能不会显著改善创伤后应激障碍或共病抑郁症的症状,尽管还需要进一步研究。