Escitalopram in the prevention of posttraumatic stress disorder: a pilot randomized controlled trial.
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ABSTRACT:
SUBMITTER: Suliman S
PROVIDER: S-EPMC4337322 | biostudies-literature | 2015 Feb
REPOSITORIES: biostudies-literature
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Escitalopram in the prevention of posttraumatic stress disorder: a pilot randomized controlled trial.
Suliman Sharain S Seedat Soraya S Pingo Janine J Sutherland Taryn T Zohar Joseph J Stein Dan J DJ
BMC psychiatry 20150219
<h4>Background</h4>A small literature suggests that pharmacotherapy may be useful in the prophylaxis of posttraumatic stress disorder in patients presenting with major trauma. There is relatively little data, however, on the use of selective serotonin reuptake inhibitors (SSRIs) in this context.<h4>Methods</h4>24 week, double-blind placebo controlled study. 31 participants presenting immediately after trauma, and meeting diagnostic criteria for full or partial acute stress disorder were randomiz ...[more]
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Project description:BackgroundBarriers to accessing in-person care can prevent veterans with posttraumatic stress disorder (PTSD) from receiving trauma-focused treatments such as exposure therapy. Mobile apps may help to address unmet need for services by offering tools for users to self-manage PTSD symptoms. Renew is a mobile mental health app that focuses on exposure therapy and incorporates a social support function designed to promote user engagement.ObjectiveWe examined the preliminary efficacy of Renew with and without support from a research staff member compared with waitlist among 93 veterans with clinically significant PTSD symptoms. We also examined the impact of study staff support on participant engagement with the app.MethodsIn a pilot randomized controlled trial, we compared Renew with and without support from a research staff member (active use condition) with waitlist (delayed use condition) over 6 weeks. Participants were recruited through online advertisements. The Posttraumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) was used to measure PTSD symptoms at pre, post, and 6-week follow-up. Usage data were collected to assess engagement with Renew.ResultsResults indicated a small effect size (d=-0.39) favoring those in the active use conditions relative to the delayed use condition, but the between-group difference was not significant (P=.29). There were no differences on indices of app engagement between the 2 active use conditions. Exploratory analyses found that the number of support persons users added to the app, but not the number of support messages received, was positively correlated with app engagement.ConclusionsFindings suggest Renew may hold promise as a self-management tool to reduce PTSD symptoms in veterans. Involving friends and family in mobile mental health apps may help bolster engagement with no additional cost to public health systems.Trial registrationClinicalTrials.gov NCT04155736; https://clinicaltrials.gov/ct2/show/NCT04155736.
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Project description:BackgroundOpen-label trials suggest that escitalopram (up to 20 mg/d) is an effective treatment for some, but not all posttraumatic stress disorder (PTSD) patients. Higher doses of escitalopram effectively reduced major depression symptoms in patients who had not responded to regular doses. The current study examines the efficacy, tolerability, and adherence to high-dose escitalopram in PTSD.MethodsForty-five PTSD patients received 12 weeks of gradually increasing doses of escitalopram reaching 40 mg daily at 4 weeks. Among those, 12 participants received regular doses of antidepressants at study onset including escitalopram (n = 7). The Clinician-Administered PTSD Scale (CAPS) evaluated PTSD symptoms severity before treatment, at 3 months (upon treatment termination), and at 6 months (maintenance effect). A 20% reduction in CAPS scores was deemed clinically significant.ResultsAdverse events and medication adherence were monitored at each clinical session. Linear mixed-models analysis showed a significant reduction of mean CAPS scores (11.5 ± 18.1 points) at 3 months and maintenance of gains by 6 months (F2,34.56 = 8.15, P = 0.001). Eleven participants (34.3%) showed clinically significant improvement at 3 months. Only 9 participants (20%) left the study. There were no serious adverse events and few mild ones with only 2 adverse events (diarrhea, 11.1%; drowsiness, 11.1%) reported by more than 10% of participants.ConclusionHigh doses of escitalopram are tolerable and well adhered to in PTSD. Their beneficial effect at a group level is due to a particularly good response in a subset of patients.Variability in prior pharmacological treatment precludes a definite attribution of the results to high doses of escitalopram.
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Project description:ContextGeneralized anxiety disorder (GAD) is one of the most common psychiatric disorders in older adults; however, few data exist to guide clinicians in efficacious and safe treatment. Selective serotonin reuptake inhibitors (SSRIs) are efficacious for younger adults with GAD, but benefits and risks may be different in older adults.ObjectiveTo examine the efficacy, safety, and tolerability of the SSRI escitalopram in older adults with GAD.Design, setting, and participantsA randomized controlled trial in primary care practices and related specialty clinics in Pittsburgh, Pennsylvania, of 177 participants aged 60 years or older with a principal diagnosis of GAD randomized to receive either escitalopram or placebo and conducted between January 2005 and January 2008.InterventionsTwelve weeks of 10 to 20 mg/d of escitalopram (n = 85) or matching placebo (n = 92).Main outcome measuresCumulative response defined by Clinical Global Impressions-Improvement score of much or very much improved; time to response; and anxiety and role functioning changes measured by the Clinical Global Impressions-Improvement scale, Hamilton Anxiety Rating Scale, Penn State Worry Questionnaire, Late-Life Function and Disability Instrument activity limitations subscale, and the role-emotional impairment and social function subscales of the Medical Outcome Survey 36-item Short Form.ResultsIn the primary analytic strategy in which participants (n = 33) were censored at the time of dropout, mean cumulative response rate for escitalopram was 69% (95% confidence interval [CI], 58%-80%) vs 51% (95% CI, 40%-62%) for placebo (P = .03). A conservative intention-to-treat analysis showed no difference in mean cumulative response rate between escitalopram and placebo (57%; 95% CI, 46%-67%; vs 45%; 95% CI, 35%-55%; P = .11). Participants treated with escitalopram showed greater improvement than with placebo in anxiety symptoms and role functioning (Clinical Global Impressions-Improvement scale: effect size, 0.93; 95% CI, 0.50-1.36; P < .001; Penn State Worry Questionnaire: 0.30; 95% CI, 0.23-0.48; P = .01; activity limitations: 0.32; 95% CI, 0.01-0.63; P = .04; and the role-emotional impairment and social function: 0.96; 95% CI, 0.03-1.90; P = .04). Adverse effects of escitalopram (P < .05 vs placebo) were fatigue or somnolence (35 patients [41.1%]), sleep disturbance (12 [14.1%]), and urinary symptoms (8 [9.4%]).ConclusionsOlder adults with GAD randomized to escitalopram had a higher cumulative response rate for improvement vs placebo over 12 weeks; however, response rates were not significantly different using an intention-to-treat analysis. Further study is required to assess efficacy and safety over longer treatment durations.Trial registrationclinicaltrials.gov Identifier: NCT00105586.
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Project description:ObjectivePosttraumatic stress disorder (PTSD) is often difficult to treat, and many patients do not achieve full remission. Complementary and integrative health approaches, such as mindfulness meditation, are intended to be integrated with evidence-based treatment. This study examined the efficacy of mindfulness-based stress reduction (MBSR) in the treatment of PTSD in U.S. military veterans.MethodsVeterans with a diagnosis of PTSD (N=214) were randomly assigned to either 90-minute group MBSR or present-centered group therapy (PCGT) for eight weeks. Follow-up assessments were obtained at baseline and weeks 3, 6, 9 (primary endpoint), and 16.ResultsBoth the MBSR and PCGT groups achieved significant improvement in PTSD as measured by the Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV), with no statistically significant differences between groups. However, compared with PCGT, the MBSR group showed a statistically significant improvement in PTSD on the self-reported PTSD Checklist for DSM-IV over the nine weeks. This difference was not maintained posttreatment, at week 16. Strengths of the study include its large sample size, multisite design, active control group, single-blind outcome ratings, fidelity monitoring, large minority representation, and randomized approach. The study was limited by its high attrition rate and low representation of women.ConclusionBoth MBSR and PCGT appear to have beneficial effects in treating PTSD in veterans, with greater improvement observed in self-reported PTSD symptoms in the MBSR group. No differences between groups were observed on the CAPS-IV scale.
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Project description:BackgroundMany individuals with posttraumatic stress disorder (PTSD) have limited access to first-line treatments, warranting the development of remotely-delivered treatments. Attention bias modification (ABM), targeting perturbed threat-related attentional patterns, shows promise when delivered in-person. However, previous studies found ABM to be ineffective when delivered remotely. Randomized clinical trials usually applied two variations of ABM: ABM away from threat or attention control training (ACT) balancing attention between threat-related and neutral stimuli. We tested remotely-delivered ACT/ABM with tighter supervision and video-based interactions that resemble in-clinic protocols. We expected to replicate the results of in-clinic trials, in which ACT outperformed ABM for PTSD.MethodsIn this double-blinded, parallel-group randomized controlled trial, 60 patients diagnosed with PTSD were randomized (ABM n = 30; ACT n = 30). Patients performed eight bi-weekly remotely-delivered supervised ABM/ACT sessions. Symptoms were assessed pre- and post-treatment with Clinician-Administered PTSD Scale 5 (CAPS-5) severity score and PTSD diagnosis as the primary outcomes. Current depressive episode, current anxiety-related comorbidity, and time elapsed since the trauma were examined as potential moderators of treatment outcome.ResultsSignificant decrease in CAPS-5 severity scores and PTSD diagnosis was observed following both ACT and ABM with no between-group difference. Patients without depression or whose trauma occurred more recently had greater symptom reduction in the ACT than the ABM group.ConclusionsContrary to our expectation, symptoms decreased similarly following ACT and ABM. Moderator analyses suggest advantage for ACT in non-depressed patients and patients whose trauma occurred more recently. Further refinements in remotely-delivered ABM/ACT may be needed.
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