Fluoxetine in the Treatment of Children with PTSD

Abstract

Introduction: Military action in Ukraine led to increasing in the number of patients with PTSD among children. Open-label studies demonstrated the efficacy of SSRI's for the treatment of PTSD, primarily paroxetine. Feasibility of using of these drugs in children and adolescents is controversial [1-2]. Objective: To evaluate a short and long-term efficacy and tolerability of fluoxetine in the treatment of PTSD in children. Methods: double-blind, placebo-controlled 12-week study with a fixed dose of fluoxetine (20-40 mg). The trial design consisted of 1-week, single-blind, placebo run-in period, followed by a 12-week treatment period and a 2-week taper phase. Were randomized 110 children aged from 12 to 18 years (MD = 14,2), that have been moved from the combat zone in the east of Ukraine and met the DSM-5criterias for PTSD. Drug efficacy was assessed weekly using the CAPS-2; CGI-I / CGI-S. Safety assessed: Adverse event (AE) recording, suicidality assessment. Result: The reduction in CAPS-2 scales was statistically significant among children randomized to fluoxetine treatment compared with placebo in a week 12 endpoint (treatment difference-11.10; 95% Cl-13.4,-7,38; p <0.001). Significant greater proportion of fluoxetine-treated patient (52%) than placebo-treated (43%) were defined as treatment responders based on CGI scale (adjusted odds ratio = 2.28; 95% Cl 1.75, 2.93; p <0.001). The most common adverse effects in fluoxetine group were somnolence, headache and irritability, each occurring in <20% patients. Conclusion: Fluoxetine at a dose of 20-40 mg / day is more effective than placebo, well-tolerated and can be recommended in pediatric practice.

Alpha-2 Agonists in Children and Adolescents With Post-traumatic Stress Disorder: A Systematic Review

“…The exact underlying mechanism of the development of PTSD following trauma yet remains to be fully understood. However, disruption of the autonomic nervous system and sympathetic response secondary to alterations in basal NE level, along with the excessive release of NE and symptoms related to this hyper-noradrenergic state following a traumatic event or its reminders, have been shown to play a role in the pathophysiology of PTSD [ 51 , 52 ]. Psychoneurological evaluation of trauma victims and neuroimaging evidence have shown associations with the structure and functioning of the brain and PTSD, especially the dysfunction of the cortical regions associated with working memory and sympathetic fight-and-flight response, including the amygdala and PFC, in response to life-threatening cues [ 13 , 53 , 54 ].…”

Post-traumatic depressions in children and adolescents

“…Більшість досліджень ефективності ПЛЗ у дітей та підлітків після травматизації мали на меті оцінювання їх ефективності при лікуванні симптомів ПТСР [57]. Окремі дослідження вказують на безпечність та ефективність флуоксетину при терапії депресивних симптомів при ПТСР у дітей та підлітків, які зазнали травматизації під час воєнних дій [46,47].…”

Use of Prazosin for Pediatric Post-Traumatic Stress Disorder With Nightmares and/or Sleep Disorder: Case Series of 18 Patients Prospectively Assessed

“…Only a few studies have prospectively and systematically evaluated the use of pharmacological agents in youth with PTSD. One open-label study with citalopram ( 12 ) and one double-blind, placebo-controlled 12-week study with a fixed dose of fluoxetine ( 13 ) demonstrated improved symptoms over the course of treatment; however, randomized controlled trials of antidepressants, both tricyclic and serotoninergic, have not shown benefit ( 14 – 16 ). Similarly, second-generation antipsychotics (SGA) may be associated with improvement in some PTSD symptoms, but these results are supported by very few pharmacological studies, limited to case series ( 17 , 18 ) and open-label studies for risperidone ( 19 ) and quetiapine ( 20 ).…”