A Randomized, Placebo-Controlled Trial of Mirtazapine for the Treatment of Posttraumatic Stress Disorder in Veterans

Davis, Lori L.; Pilkinton, Patricia; Lin, Chen; Parker, Pamela; Estes, Sandra; Bartolucci, Al

doi:10.4088/jcp.20m13267

Cited by 17 publications

(19 citation statements)

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“…Not recommended adjunctive therapies: Small RCTs failed to show the superiority of adjunctive therapy with guanfacine (Level 1, negative) [1057,1058], bupropion SR [1005] (Level 2, negative), or zolpidem [1059] (Level 2, negative). While case series suggested that adjunctive topiramate [1026,1027,1029] may be effective in treatment-resistant PTSD, a RCT failed to show superiority over placebo [1028] (Level 2, negative).…”

Section: Adjunctive Therapiesmentioning

confidence: 99%

Canadian clinical practice guidelines for the management of anxiety, posttraumatic stress and obsessive-compulsive disorders

Katzman¹,

Bleau²,

Blier³

et al. 2023

Preprint

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Background Anxiety and related disorders are among the most common mental disorders, with lifetime prevalence reportedly as high as 31%. Unfortunately, anxiety disorders are under-diagnosed and under-treated. Methods These guidelines were developed by Canadian experts in anxiety and related disorders through a consensus process. Data on the epidemiology, diagnosis, and treatment (psychological and pharmacological) were obtained through MEDLINE, PsycINFO, and manual searches (1980–2012). Treatment strategies were rated on strength of evidence, and a clinical recommendation for each intervention was made, based on global impression of efficacy, effectiveness, and side effects, using a modified version of the periodic health examination guidelines. Results These guidelines are presented in 10 sections, including an introduction, principles of diagnosis and management, six sections (Sections 3 through 8) on the specific anxiety-related disorders (panic disorder, agoraphobia, specific phobia, social anxiety disorder, generalized anxiety disorder, obsessive-compulsive disorder, and posttraumatic stress disorder), and two additional sections on special populations (children/adolescents, pregnant/lactating women, and the elderly) and clinical issues in patients with comorbid conditions. Conclusions Anxiety and related disorders are very common in clinical practice, and frequently comorbid with other psychiatric and medical conditions. Optimal management requires a good understanding of the efficacy and side effect profiles of pharmacological and psychological treatments.

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Section: Adjunctive Therapiesmentioning

confidence: 99%

Canadian clinical practice guidelines for the management of anxiety, posttraumatic stress and obsessive-compulsive disorders

Katzman¹,

Bleau²,

Blier³

et al. 2023

Preprint

View full text Add to dashboard Cite

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“…We excluded 6,671 studies due to them having unrelated themes. A full-text review was done for the remaining 87 studies and we identified 21 articles ( Davidson et al, 1990 ; Kosten et al, 1991 ; Hertzberg et al, 2000 ; Stein et al, 2002 ; Hamner et al, 2003 ; Monnelly et al, 2003 ; Akuchekian and Amanat, 2004 ; Bartzokis et al, 2005 ; Neylan et al, 2006 ; Lindley et al, 2007 ; Raskind et al, 2007 ; Davis et al, 2008 ; Baniasadi et al, 2014 ; Naylor et al, 2015 ; Petrakis et al, 2016 ; Villarreal et al, 2016 ; Ramaswamy et al, 2017 ; Rezaei Ardani et al, 2017 ; Surís et al, 2017 ; Raskind et al, 2018 ; Spangler et al, 2020 ) with 22 RCTs that meet the inclusion criteria for this meta-analysis.…”

Section: Resultsmentioning

confidence: 99%

Effectiveness, Acceptability and Safety of Pharmaceutical Management for Combat-Related PTSD in Adults Based on Systematic Review of Twenty-Two Randomized Controlled Trials

Yan

Jialing

et al. 2022

Front. Pharmacol.

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Objective: This study assessed the efficacy, acceptability, and safety of pharmaceutical management for combat-related post-traumatic stress disorder (PTSD) to provide a clinical decision-making basis for clinicians.Method: A comprehensive search was conducted using Ovid MEDLINE, Ovid EMBASE, Cochrane Library, Scopus, ScienceDirect, and Web of Science for randomized controlled trails (RCTs), which reported pharmaceutical management and placobo for adults with combat-related PTSD, that were published until April 21, 2021. The effectiveness, acceptability, and adverse events (AEs), were designed as interested outcomes. The change in total symptoms of combat-related PTSD according to the clinician rating scale was defined as primary outcome, and the others were defined as secondary outcomes.Results: Twenty-two RCTs with 1,221 patients were involved. Compared with placebo, overall active comparators had statistical differences for all outcomes, including the change in total symptoms of combat-related PTSD [SMD = −0.36, 95%CI (−0.62,−0.09)], depression [SMD = −0.28, 95%CI (−0.45,−0.10)], anxiety [SMD = −0.44, 95%CI (−0.64,−0.23)], re-experience [SMD = −0.33, 95%CI (−0.52,−0.13)], avoidance [SMD = −0.24, 95%CI (−0.43,−0.05)], and hyper-arousal [SMD = −0.26, 95%CI (−0.48,−0.03)]. Compared with the placebo, in terms of acceptability, overall active comparators did not significantly decrease all-cause discontinuance rates [RR = 0.97, 95%CI (0.78,1.20)], and the significance decreased due to AEs [RR = 2.42, 95%CI (1.41,4.13)]. Nevertheless, overall there was no statistically significant difference for overall AEs, including somnolence, sedation, dizziness, paresthesia, anxiety, blurred vision, generalized anxiety disorder, and sleep disturbance. All funnel plots were symmetrical and no publication bias was found.Conclusion: Active drugs, especially amitriptyline, imipramine, and quetiapine, had a positive effect on the improvement of combat-related PTSD symptoms. Despite there being no significant increase in the AEs of the active drugs, the fact that the discontinuation rates of these drugs, including risperidone, imipramine, and topiramate, were increased deserves attention. Furthermore, as active drugs were effective across ethnic groups and battlefields, active drug regimens were revealed to be more appropriate for treating people with symptoms of extreme severe PTSD (≥80) or PTSD that is at least 8 weeks old. In addition, current evidence was from adults under 60 years of age and male combat-related PTSD. Whether this evidence can be extended to other populations of combat-related PTSD needs to be confirmed by subsequent high-quality, large-sample studies.

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“…Characteristics of 2,331 adult patients from published double-blind, parallel 36 RCTs ( Frank et al, 1988 ; Davidson et al, 1990 ; Kosten et al, 1991 ; Hertzberg et al, 2000 ; Stein et al, 2002 ; Zohar et al, 2002 ; Hamner et al, 2003 ; Monnelly et al, 2003 ; Akuchekian & Amanat, 2004 ; Chung et al, 2004 ; Davis et al, 2004 ; Bartzokis et al, 2005 ; Neylan et al, 2006 ; Friedman et al, 2007 ; Lindley et al, 2007 ; Raskind et al, 2007 ; Davis et al, 2008a ; Davis et al, 2008b ; Hamner et al, 2009 ; Krystal et al, 2011 ; Panahi et al, 2011 ; Germain et al, 2012 ; Litz et al, 2012 ; Baniasadi et al, 2014 ; Batki et al, 2014 ; Manteghi et al, 2014 ; Rothbaum et al, 2014 ; Naylor et al, 2015 ; Back et al, 2016 ; Petrakis et al, 2016 ; Rodgman et al, 2016 ; Villarreal et al, 2016 ; Ramaswamy et al, 2017 ; Rezaei Ardani et al, 2017 ; Surís et al, 2017 ; Raskind et al, 2018 ) were described in the study. Among them, three studies ( Frank et al, 1988 ; Kosten et al, 1991 ; Rothbaum et al, 2014 ) reported active-comparator experiments.…”

Section: Resultsmentioning

confidence: 99%

“…Among them, three studies ( Frank et al, 1988 ; Kosten et al, 1991 ; Rothbaum et al, 2014 ) reported active-comparator experiments. Our research involves a variety of drug types, including atypical antipsychotics (AASs) ( Stein et al, 2002 ; Monnelly et al, 2003 ; Bartzokis et al, 2005 ; Hamner et al, 2009 ; Krystal et al, 2011 ; Naylor et al, 2015 ; Villarreal et al, 2016 ), corticosteroids ( Surís et al, 2017 ), alpha blockers ( Raskind et al, 2007 ; Germain et al, 2012 ; Petrakis et al, 2016 ; Rodgman et al, 2016 ; Raskind et al, 2018 ), anticonvulsants ( Hamner et al, 2003 ; Akuchekian & Amanat, 2004 ; Lindley et al, 2007 ; Davis et al, 2008a ; Batki et al, 2014 ), central muscle relaxants ( Manteghi et al, 2014 ), D-cycloserine ( Litz et al, 2012 ; Rothbaum et al, 2014 ), N-acetylcysteine ( Back et al, 2016 ), γ-aminobutyric acid ( Baniasadi et al, 2014 ), reversible cholinesterase inhibitor ( Rezaei Ardani et al, 2017 ), serotonin antagonist and reuptake inhibitors (SARIs) ( Davis et al, 2004 ); SSRIs ( Hertzberg et al, 2000 ; Zohar et al, 2002 ; Friedman et al, 2007 ; Panahi et al, 2011 ; Ramaswamy et al, 2017 ), tricyclic antidepressants (TCAs) ( Frank et al, 1988 ; Davidson et al, 1990 ; Kosten et al, 1991 ), α2 receptor agonist ( Chung et al, 2004 ; Neylan et al, 2006 ; Davis et al, 2008b ), pregabalin ( Baniasadi et al, 2014 ) and monoamine oxidase inhibitors (MAOIs) ( Frank et al, 1988 ; Kosten et al, 1991 ). All patients were diagnosed as PTSD by different versions of the DSM scale.…”

Section: Resultsmentioning

confidence: 99%

Key Clinical Interest Outcomes of Pharmaceutical Administration for Veterans With Post-Traumatic Stress Disorder Based on Pooled Evidences of 36 Randomised Controlled Trials With 2,331 Adults

et al. 2020

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Background: The effects of drug treatment on veterans, who have a high risk of post-traumatic stress disorder (PTSD), are not clear, and the guidelines are different from the recommendations of the recent meta-analysis. Our goal was to find the efficacy and frequencies of complications of drugs that can treat PTSD in veterans.Method: We searched Ovid MEDLINE, Ovid Embase, The Cochrane Library and Web of Science until January 1, 2020. The outcomes were designed as the change of PTSD total scale, subsymptom score, response rate, frequencies of complications outcomes, and acceptability.Results: We included a total of 36 randomised controlled trials with a total of 2,331 adults. In terms of overall effect, drug treatment is more effective than placebo in change in total PTSD symptoms scale (SMD = −0.24, 95% CI [−0.42, −0.06]) and response (RR = 1.66, 95% CI [1.01, 2.72]). However, in terms of frequencies of complications, drugs generally had a higher withdrawal rate (RR = 1.02, 95% CI [0.86, 1.20]) and a higher frequencies of complications (RR = 1.72, 95% CI [1.20, 2.47]) than placebo. Risperidone showed a good curative effect in change in total PTSD symptoms scale (SMD = −0.22, 95% CI [−0.43, 0.00]) and acceptability (RR = 1.31, 95% CI [0.82, 2.59]). The drugs acting on 5−HT receptors, our results showed that symptoms of hyper−arousal (SMD = −0.54, 95% CI [−0.86, −0.21]), symptoms of re−experiencing (SMD = −0.62, 95% CI [−0.86, −0.39]) and symptoms of avoidance (SMD = −0.53, 95% CI [− 0.77,−0.3]), The drugs acting on dopamine receptors, our results showed that symptoms of re−experiencing (SMD = −0.35, 95% CI [−0.55, −0.16]) and the drugs acting on α2 receptor has a significant effect on reducing total PTSD symptoms scale (SMD = −0.34, 95% CI [−0.62, −0.06]).Conclusion: Drug therapy can effectively treat PTSD, but its frequencies of complications should be considered. Different from the guidelines for adult PTSD, this study supports atypical antipsychotics, selective serotonin reuptake inhibitors and receptors that act on 5-HT and dopamine for the treatment of PTSD in veterans. Based on evidence among these drugs, the risperidone is the most effective for veterans, otherwise, sertraline is used as an alternative.

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A Randomized, Placebo-Controlled Trial of Mirtazapine for the Treatment of Posttraumatic Stress Disorder in Veterans

Cited by 17 publications

References 0 publications

Canadian clinical practice guidelines for the management of anxiety, posttraumatic stress and obsessive-compulsive disorders

Canadian clinical practice guidelines for the management of anxiety, posttraumatic stress and obsessive-compulsive disorders

Effectiveness, Acceptability and Safety of Pharmaceutical Management for Combat-Related PTSD in Adults Based on Systematic Review of Twenty-Two Randomized Controlled Trials

Key Clinical Interest Outcomes of Pharmaceutical Administration for Veterans With Post-Traumatic Stress Disorder Based on Pooled Evidences of 36 Randomised Controlled Trials With 2,331 Adults

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