Pharmacotherapy of post‐traumatic stress disorder with a novel psychotropic

Abstract

This was a multicenter, randomized, double-blind, parallel trial conducted in outpatients in three countries. Following screening and placebo washout, patients received brofaromine (a combined MAO-A inhibitor/5-HT transport inhibitor) or placebo in a flexible dosing design. Based upon the CAPS, a standardized post-traumatic stress disorder (PTSD) interview, findings from a cohort involving both subchronic and chronic traumatic stress marginally favored brofaromine over placebo; however, not to a statistically significant degree. With a more conservation definition of the syndrome, employing a primary cohort of patients with PTSD of one year or greater duration, brofaromine significantly reduced PTSD symptoms in comparison with placebo. In all analyses a substantial proportion of patients in both drug and placebo groups remained symptomatic throughout. Findings were supported by an analysis of secondary measures. Brofaromine may be of benefit in the therapy of PTSD.

Efficacy and Safety of Sertraline Treatment of Posttraumatic Stress Disorder

“…In the efficacy analysis, 53% of patients were much or very much improved at treatment end point (P=.008 vs placebo), with 70% of the reduction in PTSD symptom severity on the CAPS-2 and IES achieved within the first 4 weeks of treatment ( Figure 2). The placebo response rate of 32% was comparable with what has been observed in previous multicenter PTSD clinical trials 23,24 as well as across most acute treatment studies of patients diagnosed as having affective or anxiety disorders.…”

Posttraumatic Stress Disorder: Diagnosis and Epidemiology, Comorbidity and Social Consequences, Biology and Treatment

“…In a US study, carried out predominantly among combat veterans, brofaromine failed to beat placebo on PTSD-specific measures [87], but showed good effect on a general global scale [88]. In the European study, Katz et al [89] reported a tendency for brofaromine to be more effective than placebo among those with the more chronic form of PTSD (i.e. lasting longer than 1 year), and on a global scale, the drug was statistically superior to placebo.…”

Neurobiology of Placebo Effect

“…[69] Post-travmatik stres bozukluğu (PTSB) hastalarında psikofarmakolojik tedaviye yanıtın %17 ile %68 arasında olduğu, öte yandan aynı hastalarda plasebo kullanımı sonrası yanıtın ise %28 ile %62 arasında olduğu bildirilmiş-tir. [70][71][72] Birçok çalışmada PTSB hastalarında tıbbi tedavi ile plasebo arasında fark olmadığı şeklinde veriler elde edilmiştir. [70][71][72][73][74] PTSB hastalarında plaseboya yanıtın yüksek olması ve PTSB'nin oluşumunda endojen opioidlerin rol oynaması, plasebo yanıtının oluşmasında endojen opioidlerinin etkisi olduğunu gündeme getirmiştir.…”

“…[70][71][72] Birçok çalışmada PTSB hastalarında tıbbi tedavi ile plasebo arasında fark olmadığı şeklinde veriler elde edilmiştir. [70][71][72][73][74] PTSB hastalarında plaseboya yanıtın yüksek olması ve PTSB'nin oluşumunda endojen opioidlerin rol oynaması, plasebo yanıtının oluşmasında endojen opioidlerinin etkisi olduğunu gündeme getirmiştir. [75] PTSB hastalarına ekzojen opioid verildiğinde içe çekilme ve aşırı uyarılmışlık belirtilerinde iyileşme olması, plasebonun da özellikle bu belirtilere endojen opioid sistemi üzerinden etkili olacağı-nı düşündürmektedir.…”