Randomized, Double-Blind Comparison of Sertraline and Placebo for Posttraumatic Stress Disorder in a Department of Veterans Affairs Setting

Friedman, Matthew J.; Marmar, Charles R.; Baker, Dewleen G.; Sikes, Carolyn; Farfel, Gail

doi:10.4088/jcp.v68n0508

Cited by 219 publications

(135 citation statements)

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“…44,45 The severity and comorbidity in VA PTSD patients have been cited as reasons for smaller effects of evidence based PTSD treatment in this population. 43,46 It also would be premature to conclude from our study or from existing evidence that collaborative care is not effective for managing PTSD. Research is at an early stage, e.g., a randomized trial of stepped care for acute PTSD is underway.…”

Section: Discussioncontrasting

confidence: 39%

RESPECT-PTSD: Re-Engineering Systems for the Primary Care Treatment of PTSD, A Randomized Controlled Trial

et al. 2012

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Section: Discussioncontrasting

confidence: 39%

RESPECT-PTSD: Re-Engineering Systems for the Primary Care Treatment of PTSD, A Randomized Controlled Trial

et al. 2012

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“…Á Sertraline was effective in a number of DBPC studies (Brady et al 2000;Davidson et al 2001b;Stein et al 2006;Zohar et al 2002). One trial did not find a difference between sertraline and placebo (Friedman et al 2007a). …”

Section: Post-traumatic Stress Disorder (Ptsd)mentioning

confidence: 99%

World Federation of Societies of Biological Psychiatry (WFSBP) Guidelines for the Pharmacological Treatment of Anxiety, Obsessive-Compulsive and Post-Traumatic Stress Disorders – First Revision

Bandelow

Zohar

Hollander

et al. 2008

The World Journal of Biological Psychiatry

712

410

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In this report, which is an update of a guideline published in 2002 (Bandelow et al. 2002, recommendations for the pharmacological treatment of anxiety disorder, obsessive-compulsive disorder (OCD) and post-traumatic stress disorder (PTSD) are presented. Since the publication of the first version of this guideline, a substantial number of new randomized controlled studies of anxiolytics have been published. In particular, more relapse prevention studies are now available that show sustained efficacy of anxiolytic drugs. The recommendations, developed by the World Federation of Societies of Biological Psychiatry (WFSBP) Task Force for the Pharmacological Treatment of Anxiety, Obsessive-Compulsive and Post-Traumatic Stress Disorders, a consensus panel of 30 international experts, are now based on 510 published randomized, placebo-or comparator-controlled clinical studies (RCTs) and 130 open studies and case reports. First-line treatments for these disorders are selective serotonin reuptake inhibitors (SSRIs), serotonin-noradrenaline reuptake inhibitors (SNRIs) and the calcium channel modulator pregabalin. Tricyclic antidepressants (TCAs) are equally effective for some disorders, but many are less well tolerated than the SSRIs/ SNRIs. In treatment-resistant cases, benzodiazepines may be used when the patient does not have a history of substance abuse disorders. Potential treatment options for patients unresponsive to standard treatments are described in this overview. Although these guidelines focus on medications, non-pharmacological were also considered. Cognitive behavioural therapy (CBT) and other variants of behaviour therapy have been sufficiently investigated in controlled studies in patients with anxiety disorders, OCD, and PTSD to support them being recommended either alone or in combination with the above medicines.

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“…It is also important to avoid sedation, weight gain, decreased libido, and other adverse effects of psychotropic drugs that can interfere with service members' training, mission performance, and quality of life. Although the only two drugs approved for PTSD by the Food and Drug Administration (FDA) are selective serotonin reuptake inhibitors (SSRIs), it has been difficult to demonstrate SSRI efficacy for PTSD in U.S. military veterans (4)(5)(6). Enhanced CNS adrenergic activity contributes to the pathophysiology of PTSD (7)(8)(9).…”

Section: Key Research Accomplishmentsmentioning

confidence: 99%

A Placebo-Controlled Augmentation Trial of Prazosin for Combat Trauma PTSD

Raskind¹

2013

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Public reporting burden for this collection of information is estimated to average 1 hour per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing this collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to Department of Defense, Washington Headquarters Services, Directorate for Information ABSTRACTTrauma content nightmares and sleep disturbance are among the most distressing and debilitating symptoms of military posttraumatic stress disorder (PTSD). We performed a randomized placebo-controlled trial of prazosin, a brain-active alpha-1 adrenoreceptor antagonist, for PTSD nightmares, sleep disturbance, ability to function, and overall PTSD severity in 67 active duty Service Members returned from combat deployments in Iraq and Afghanistan and stationed at Joint Base LewisMcChord, Washington. Prazosin or placebo were titrated upward over six weeks guided by trauma nightmare reduction. Achieved doses were continued for an additional nine weeks. Mean achieved prazosin doses were 4.0 +/-1.4 mg at midmorning and 15.6 +/-6.0 at bedtime. Prazosin was significantly superior to placebo for reducing trauma nightmares, improving sleep quality, improving global function and reducing total PTSD symptom scores. Prazosin was well tolerated, with no differences between prazosin and placebo on blood pressure or adverse events.These results suggest that prazosin is a useful treatment for combat-induced PTSD in active duty Service Members with distressing nighttime PTSD symptoms. Body:Active duty OEF/OIF/OND combat-experienced Service Members with PTSD and frequent distressing combat trauma nightmares were recruited through banners on post, educational briefings with commanders and Army medical providers, and "word of mouth." Six weeks of flexible dose titration guided by treatment effect on trauma nightmares were followed by 9 weeks at the achieved dose for a total study duration of 15 weeks. Previous clinical prazosin experience with OEF/OIF/OND Service Members and Veterans suggested that higher doses than previously used in Vietnam Veterans often were necessary to achieve adequate symptom reduction. Therefore, maximum prazosin dose regimen was 5 mg midmorning and 20 mg at bedtime. Primary outcome measures were the "nightmare" item from the Clinician Administered PTSD Scale (CAPS), the Pittsburgh Sleep Quality Index, (PSQI), and the Clinical Global Impression of Change (CGIC) anchored to ability to function at work and at home. Secondary outcome measures were CAPS total score, CAPS subscale scores, PSQ-9 depression score and Quality of Life Index. Behavioral, blood pressure and adverse event ratings for analysis were obtained at weeks 7, 11 and 16. An intent to treat mixed effects model analysis of all data from randomized subjects was performed. Key Research Accomplishments1. We successfully complet...

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Randomized, Double-Blind Comparison of Sertraline and Placebo for Posttraumatic Stress Disorder in a Department of Veterans Affairs Setting

Cited by 219 publications

References 0 publications

RESPECT-PTSD: Re-Engineering Systems for the Primary Care Treatment of PTSD, A Randomized Controlled Trial

RESPECT-PTSD: Re-Engineering Systems for the Primary Care Treatment of PTSD, A Randomized Controlled Trial

World Federation of Societies of Biological Psychiatry (WFSBP) Guidelines for the Pharmacological Treatment of Anxiety, Obsessive-Compulsive and Post-Traumatic Stress Disorders – First Revision

A Placebo-Controlled Augmentation Trial of Prazosin for Combat Trauma PTSD

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