scholarly journals 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

2020 ◽  
Vol 10 (3) ◽  
pp. 21-28 ◽  
Author(s):  
Sheila M Dowd ◽  
Alyson K Zalta ◽  
Helen J Burgess ◽  
Elizabeth E Adkins ◽  
Zerbrina Valdespino-Hayden ◽  
...  
2002 ◽  
Vol 181 (4) ◽  
pp. 315-320 ◽  
Author(s):  
Ferenc Martenyi ◽  
Eileen B. Brown ◽  
Harry Zhang ◽  
Stephanie C. Koke ◽  
Apurva Prakash

BackgroundLittle is known about the effect of pharmacotherapy in the prevention of post-traumatic stress disorder (PTSD) relapse.AimsTo assess the efficacy and tolerability of fluoxetine in preventing PTSD relapse.MethodThis was a double-blind, randomised, placebo-controlled study. Following 12 weeks of acute treatment, patients who responded were re-randomised and continued in a 24-week relapse prevention phase with fluoxetine (n=69) or placebo (n=62). The primary efficacy assessment was the prevention of PTSD relapse, based on the time to relapse.ResultsPatients in the fluoxetine/fluoxetine group were less likely to relapse than patients in the fluoxetine/placebo group (P=0.027). There were no clinically significant differences in treatment-emergent adverse events between treatment groups.ConclusionsFluoxetine is effective and well tolerated in the prevention of PTSD relapse for up to 6 months.


2022 ◽  
Author(s):  
riadh boukef ◽  
rym youssef ◽  
hajer yaacoubi ◽  
imen trabelsi ◽  
adel sekma ◽  
...  

Introduction: The prevention from Post-traumatic stress disorder (PTSD) is therefore of major public health interest and one of the concerns of any emergency physician. The purpose of our study was to evaluate the efficacy and safety of an herbal supplement to prevent the occurrence of PTSD in high-risk patients. Methods: It is a randomized, double-blind, prospective, interventional study including patients exposed to a potentially traumatic event that meets DSM-V Criterion A and has a Peri-traumatic Distress Inventory score or the Questionnary for traumatic dissociation experiments (PDEQ) and/or L.Crocq score higher than the thresholds between day 1 and day 3. Two hundred patients were included randomly assigned into two groups: Aleozen group and placebo group. Patients included in aleozen group received Aleozen® for 10 days while patients in placebo group received Placebo. A CAPS-5 assessment was performed for all patients at different moments. The main objective was to assess the efficacy of Aleozen after 90 days of an exposition to traumatic events according to PTSD. Secondary objectives were to evaluate the safety of Aleozen® at 10 and 30 days after its administration and PTSD in the study population after one year of inclusion. Results: No statistical differences were noted between the two groups in term of baseline characteristics including age, sex and the ISS score. After 90 days of follow-up, and according to the CAPS-5 scale, 85 patients (42.5%) of the population study showed PTSD. Concerning primary endpoint, less PTSD were seen in intervention group compared to placebo group (38.8% versus 61.2% respectively; p<0.001). During the study, no adverse events were noted. Conclusion: Results of this work suggest the potential preventive effects of an herbal supplement on PTSD for traumatic patient in emergency. Further confirmatory studies are needed.


Sign in / Sign up

Export Citation Format

Share Document