Effects of suvorexant on the Insomnia Severity Index in patients with insomnia: analysis of pooled phase 3 data.

Objective: Suvorexant is an orexin receptor antagonist that is approved in the US, Japan and Australia for the treatment of insomnia. Using outcomes from the Insomnia Severity Index (ISI) in the core registration studies, we explored suvorexant effects on sleep problems and their impact on daytime function.

Methods: Data were pooled from two similar Phase 3, randomized, double-blind, placebo-controlled, parallel-group, three-month trials in elderly (≥65 years) and non-elderly (18-64 years old) insomnia patients.

Phase II Proof-of-Concept Trial of the Orexin Receptor Antagonist Filorexant (MK-6096) in Patients with Major Depressive Disorder.

Background: We evaluated the orexin receptor antagonist filorexant (MK-6096) for treatment augmentation in patients with major depressive disorder.

Methods: We conducted a 6-week, double-blind, placebo-controlled, parallel-group, Phase II, proof-of-concept study. Patients with major depressive disorder (partial responders to ongoing antidepressant therapy) were randomized 1:1 to once-daily oral filorexant 10 mg or matching placebo.

Orexin Receptor Antagonism in Painful Diabetic Neuropathy: A Phase 2 Trial With Filorexant.

Objectives: To evaluate whether orexin receptor antagonism with filorexant provides pain relief in patients with painful diabetic neuropathy (PDN).

Methods: In this double-blind, placebo-controlled, enriched-enrollment, randomized-withdrawal proof-of-concept study, patients with PDN (aged 18 to 75 y) entered a 2-week, single-blind active run-in period with filorexant 10 mg nightly, before randomization 1:1 to placebo or filorexant in a 2-week, double-blind treatment period. The primary efficacy endpoint was time to efficacy failure among "primary responders" (≥30% decrease in evening pain intensity during the run-in).

Suvorexant in Elderly Patients with Insomnia: Pooled Analyses of Data from Phase III Randomized Controlled Clinical Trials.

Objective: Suvorexant is an orexin receptor antagonist approved for treating insomnia at doses of 10-20 mg. Previously reported phase III results showed that suvorexant was effective and well-tolerated in a combined-age population (elderly and nonelderly adults). The present analysis evaluated the clinical profile of suvorexant specifically in the elderly.

Clinical profile of suvorexant for the treatment of insomnia over 3 months in women and men: subgroup analysis of pooled phase-3 data.

Rationale: Sex-related differences in the clinical profiles of some insomnia medications have been previously reported.

Objective: To evaluate the clinical profile of suvorexant, a novel orexin receptor antagonist approved for treating insomnia at doses up to 20 mg, by sex subgroups.

Methods: Efficacy analyses by sex were based on pooled data from two similar phase 3, randomized, double-blind, placebo-controlled, 3-month trials in elderly (≥65 years) and non-elderly (18-64 years) insomnia patients.

Effects of suvorexant on sleep architecture and power spectral profile in patients with insomnia: analysis of pooled phase 3 data.

Background: The orexin receptor antagonist, suvorexant, is approved for treating insomnia at a maximum dose of 20 mg. We evaluated its effects on sleep architecture.

Methods: The analyses included pooled polysomnography data from two similar randomized, double-blind, placebo-controlled, 3-month trials evaluating two age-adjusted (non-elderly/elderly) dose regimes of 20/15 mg and 40/30 mg in 1482 patients with insomnia.

A Phase II Dose-Ranging Study Evaluating the Efficacy and Safety of the Orexin Receptor Antagonist Filorexant (MK-6096) in Patients with Primary Insomnia.

Background: Filorexant (MK-6096) is an orexin receptor antagonist; here, we evaluate the efficacy of filorexant in the treatment of insomnia in adults.

Methods: A double-blind, placebo-controlled, randomized, two 4-week-period, adaptive crossover polysomnography study was conducted at 51 sites worldwide. Patients (18 to <65 years) with insomnia received 1 of 4 doses of oral filorexant (2.

Suvorexant in Patients With Insomnia: Results From Two 3-Month Randomized Controlled Clinical Trials.

Background: Suvorexant is an orexin receptor antagonist for treatment of insomnia. We report results from two pivotal phase 3 trials.

Methods: Two randomized, double-blind, placebo-controlled, parallel-group, 3-month trials in nonelderly (18-64 years) and elderly (≥65 years) patients with insomnia.

Randomized controlled trial of the CGRP receptor antagonist telcagepant for migraine prevention.

Objective: To evaluate whether the calcitonin gene-related peptide (CGRP) receptor antagonist telcagepant might be effective for migraine prevention.

Methods: In this randomized, double-blind, placebo-controlled, multicenter trial (ClinicalTrials.gov NCT00797667), patients experiencing 3-14 migraine days during a 4-week baseline were randomized to telcagepant 140 mg, telcagepant 280 mg, or placebo twice daily for 12 weeks.

Randomized controlled trial of the orexin receptor antagonist filorexant for migraine prophylaxis.

Background: This study explored whether antagonism of orexin receptors might be an effective mechanism for migraine prevention.

Methods: We conducted a randomized, double-blind, placebo-controlled, pilot trial. Patients experiencing four to 14 days with migraine during a one-month baseline period were randomized to the orexin receptor antagonist filorexant 10 mg nightly or placebo for three months.

The sleep effects of tiagabine on the first night of treatment predict post-traumatic stress disorder response at three weeks.

Introduction: We sought to test the hypothesis that improvements in sleep might mediate treatment-related improvements in daytime symptoms of post-traumatic stress disorder (PTSD). We evaluated whether changes in sleep occurring on the first night of tiagabine (a gamma-amino butyric acid (GABA) reuptake inhibitor) administration predicted subsequent PTSD response.

Methods: This was an open-label three-week polysomnographic (PSG) study of nightly treatment with tiagabine dosing from 2-12 mg including 20 adults with PTSD with ≥30 min of self-reported and PSG wake time after sleep onset (WASO).

Long-term open-label safety study of rizatriptan acute treatment in pediatric migraineurs.

Objective: To evaluate the safety/tolerability of rizatriptan in the long-term acute treatment of migraine in pediatric patients.

Background: Acute migraine treatment options for children are limited. A recent single-attack trial demonstrated that rizatriptan is effective in eliminating migraine headache pain in this population.

Rizatriptan for treatment of acute migraine in patients taking topiramate for migraine prophylaxis.

Objective: To assess efficacy and tolerability of rizatriptan orally disintegrating tablet (ODT) for treatment of acute migraine in patients using topiramate for migraine prophylaxis.

Background: There are limited data from prospective controlled trials demonstrating the benefit of triptans in patients who experience migraine attacks while taking prophylactic medication.

Methods: This was a worldwide, randomized, placebo-controlled, double-blind, multiple-attack study in adults with a >1-year history of migraine taking a stable dose of topiramate for migraine prophylaxis and experiencing ≥2 moderate/severe attacks per month.

Efficacy and tolerability of rizatriptan for the treatment of acute migraine in sumatriptan non-responders.

Objective: The study was carried out to assess the efficacy and tolerability of rizatriptan orally disintegrating tablet (ODT) for treating acute migraine in patients who are non-responders to sumatriptan.

Background: Many migraineurs report dissatisfaction with sumatriptan efficacy. It is unclear whether sumatriptan 100 mg non-responders will respond to other triptans.

Long-term tolerability of telcagepant for acute treatment of migraine in a randomized trial.

Objective: To evaluate the long-term tolerability of telcagepant for acute treatment of intermittent migraine attacks. Background.- Telcagepant is a calcitonin gene-related peptide (CGRP) receptor antagonist being investigated for the acute treatment of migraine.

Rizatriptan 10-mg ODT for early treatment of migraine and impact of migraine education on treatment response.

Objective: To examine the efficacy of rizatriptan 10-mg orally disintegrating tablet (ODT) for treating migraines of mild intensity soon after onset, with or without patient-specific migraine education.

Background: Studies have shown rizatriptan tablet efficacy in early migraine treatment.

Methods: In this randomized, placebo-controlled, double-blind, factorial design study, adults with a history of migraine were assigned to rizatriptan 10-mg ODT patient education (personalized summary of early migraine signs and symptoms) or placebo patient education in a 1 : 1 : 1 : 1 ratio.

The impairment of Presidents Pierce and Coolidge after traumatic bereavement.

The impact of bereavement in heads of government has been little studied. Two US presidents lost their teenaged sons in a traumatic manner, leaving them profoundly affected as they struggled to serve in office. We describe the bereavements of Presidents Franklin Pierce and Calvin Coolidge, using biographical and source material.

Paroxetine CR augmentation for posttraumatic stress disorder refractory to prolonged exposure therapy.

Objective: Little is known about the efficacy of "next step" strategies for patients with post-traumatic stress disorder (PTSD) who remain symptomatic despite treatment. This study prospectively examines the relative efficacy of augmentation of continued prolonged exposure therapy (PE) with paroxetine CR versus placebo for individuals remaining symptomatic despite a course of PE.

Method: Adult outpatients meeting DSM-IV criteria for PTSD were recruited from February 2003 to September 2005 at 4 academic centers.

Placebo-controlled trial of risperidone augmentation for selective serotonin reuptake inhibitor-resistant civilian posttraumatic stress disorder.

Objective: Treatment of posttraumatic stress disorder (PTSD) with pharmacotherapy is promising, although the response to medication has generally been modest, and strategies to improve the response to antidepressant medications are needed. The primary objective of this study was to examine risperidone augmentation in civilians with PTSD currently receiving sertraline without an optimal response.

Method: Male and female participants aged 18 to 65 years were recruited from 3 academic medical centers between June 2004 and September 2006.

Modification effects of coping on post-traumatic morbidity among earthquake rescuers.

This study aims to investigate the modification effects of coping strategies on the relationships between rescue effort and psychiatric morbidity (i.e. general psychiatric morbidity and post-traumatic morbidity) in earthquake rescue workers.

Quetiapine augmentation of paroxetine CR for the treatment of refractory generalized anxiety disorder: preliminary findings.

Rationale: More data are needed to guide "next step" strategies for patients with generalized anxiety disorder (GAD) remaining symptomatic despite initial pharmacotherapy.

Objective: This study prospectively examined the relative efficacy of quetiapine versus placebo augmentation for individuals with GAD remaining symptomatic with initial paroxetine CR pharmacotherapy.

Materials And Methods: Adult outpatients with GAD were recruited from 2004 to 2007 at two academic centers.

Escitalopram in specific phobia: results of a placebo-controlled pilot trial.

Objective: To assess the efficacy and safety of escitalopram in treating specific phobia.

Method: The study was performed in an academic medical center. Adults meeting DSM-IV criteria for specific phobia were randomly assigned to 12 weeks of double-blind treatment with escitalopram or placebo.

Traumatic events and posttraumatic stress in cross-cultural mission assignments.

In addition to cross-cultural and environmental stressors, aid workers and missionaries are frequently exposed to trauma. We explored the frequency of traumatic events, their mental health impact, and factors associated with posttraumatic stress in two groups of missionaries, one representing a predominantly stable setting (Europe) and the other an unstable setting (West Africa). The 256 participants completed self-report measures assessing lifetime traumatic events, current posttraumatic stress, depressive and anxiety symptoms, resilience, and functioning.

Quetiapine as monotherapy for social anxiety disorder: a placebo-controlled study.

Social anxiety disorder (SAD) is one of the most common anxiety disorders. Reports have suggested an effect of the atypical antipsychotic quetiapine in anxiety disorders. Given these considerations, we conducted a controlled trial of quetiapine monotherapy in SAD.