Background/Aims Suicide is a major public health concern, yet there are very few randomized clinical trials that have been conducted to reduce suicidal ideation in patients at risk for suicide. We describe the rationale and refinements of such a trial that is designed to assess the effect of a hypnotic medication on suicidal ideation in adult outpatients currently experiencing suicidal ideation. Methods “Reducing Suicidal Ideation Through Insomnia Treatment (REST-IT)” is a multi-site randomized clinical trial that includes 3 recruiting sites and one data management site. This 4-year study is in its second year of recruitment. The purpose of the study is to compare hypnotic medication versus placebo as an add-on treatment to a selective serotonin reuptake inhibitor as a means of reducing suicidal ideation in depressed adult outpatients with insomnia and suicidal ideation. The safety features of the study follow the 2001 NIH guidelines for studies that include patients at risk of suicide. Results Five hundred and eighty-four potential participants have undergone telephone screening; 67% of these failed the phone screen, most often due to an absence of expressed suicidal ideation (26% of the telephone screen fails). One hundred and twelve persons appeared for a face-to-face baseline assessment, and 40 of these had completed a taper of their ineffective psychotropic medications before the baseline assessments. Sixty-four% of those who completed baseline assessments failed to proceed to randomization, most commonly because of no clinically significant suicidal ideation (51% of those excluded at baseline). One participant was offered and accepted voluntary psychiatric hospitalization in lieu of study participation. Thus far, 40 participants have been randomized into the study, 88.7% of scheduled visits have been attended, with 93.8% adherence for the SSRI and 91.6% adherence for the randomized hypnotic versus placebo. None of the randomized participants have required hospitalization or had a suicide attempt. Conclusions By carefully considering the inclusion and exclusion criteria and other safety features, the safe conduct of randomized clinical trials in suicidal adult patients is possible, including the inclusion of participants who have undergone a prescribed tapering of psychotropic medications prior to baseline assessment.
A novel corona virus, severe acute respiratory syndrome coronavirus-2, found in Wuhan, China in December 2019 has since spread to multiple continents and has been implicated in thousands of deaths. This pandemic—causing virus has been initially described (corona virus disease 2019 [COVID-19]) with the presentation of fever, cough, and shortness of breath. The majority of studies published have been conducted on inpatient cases and a shortage of tests has encouraged screening only of patients with classic presentation. A positive COVID-19 case of a healthy military male, with the chief complaint of anosmia and ageusia, instigated local re-evaluation of the screening protocol for possible COVID-19 patients. Multiple studies in Europe have implicated anosmia and ageusia as symptoms associated with COVID-19, and subsequently, anosmia and ageusia have been added to Centers for Disease Control and Prevention screening guidelines as well. There should be a higher index of suspicion when evaluating a patient with high-risk activities, travel, and atypical symptoms. More studies need to be conducted with a healthy outpatient population to further understand this disease and decrease its impact.
Akathisia and restless legs syndrome (RLS) share some common clinical features and a common relationship with dopamine dysfunction. However, the underlying causes and appropriate treatments for akathisia and RLS are different. Herein we describe a case of RLS that was precipitated by a single dose of asenapine, which is an atypical antipsychotic, and dissect the features that support the contention that this was indeed a case of RLS and not akathisia.
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