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Objective: Lock to Live is an interactive web-based lethal means safety decision aid that promotes temporary storage of firearms and medications. It has primarily been provided to suicidal patients in emergency department settings. The goal of this study was to evaluate the feasibility and acceptability of the Lock to Live decision aid with hospitalized adults at increased risk of suicide., Methods: Subjects provided demographic information and completed the Columbia-Suicide Severity Rating Scale after which they completed the Lock to Live program followed by a survey., Results: Twenty participants were recruited for this study, 5 of whom had access to firearms and 19 of whom had access to medications. Lock to Live was feasible to use as the mean length of time to complete the program was 10.0±5.3 minutes. It was acceptable to most participants as 75% of participants found it to be easy to use, and 65% of participants agreed that Lock to Live was helpful in making a decision about changing access to firearms/medications., Conclusion: Lock 2 Live decision aid appears to be a feasible and acceptable tool for hospitalized patients at risk for suicide., Competing Interests: The authors declare no conflicts of interest., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Suicide is a serious and growing public health concern yet randomized controlled trials (RCTs) that inform pharmacologic treatment remain limited. We emphasize the overall need for such trials and review the literature to highlight examples of trials that have aimed to study patients at elevated risk of suicide. We discuss key examples of existing psychotropic medication trials as well as psychotherapy intervention studies that can yield important design insights. Medications that have been studied in individuals at risk for suicide include lithium, clozapine, zolpidem, prazosin, ketamine, esketamine, and aripiprazole. While important design challenges should be considered-RCTs to study suicide are feasible and much needed. Issues such as overall trial design, patient-selection criteria, and the scales/tools used to assess suicidality are discussed., (© 2023. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Objective: Persons with mental health disorders, including suicidality, are underrepresented in clinical trials, undermining the generalizability of results and possibly contributing to health inequities. This report (1) documents the exclusion of persons with suicidality in trials used to secure US Food and Drug Administration (FDA) approval for antidepressants, (2) describes barriers to inclusion, and (3) identifies possible steps for overcoming barriers., Methods: Inclusion and exclusion criteria for efficacy trials for depression or major depressive disorder described on FDA labels for 14 antidepressants approved from 1991 through 2013 were studied by reading the FDA labels, publications described on labels, and ClinicalTrials.gov entries for registered trials. Labels for drugs approved in or before 1998 were obtained through a Freedom of Information Act request filed June 26, 2018. For drugs approved after 1998, labels are on the FDA website. Publications based on the trials described on FDA labels were identified through a PubMed search on October 23, 2018, using each drug name and trial or study as the keywords and setting no date limit., Results: For drugs approved from 1991 to 2000, of 36 publications identified, 26 did not mention suicidality, 7 excluded persons with suicidality but did not describe assessing suicidality with an instrument, 2 excluded persons with suicidality and described assessing suicidality using at least 1 instrument, and 1 included persons with suicidality. For drugs approved from 2000 through 2013, of 28 publications identified, 4 did not mention suicidality, 12 reported excluding persons with suicidality but did not describe assessing suicidality with an instrument, 12 excluded persons with suicidality and described assessing suicidality using at least one instrument, and none included persons with suicidality. More stringent criteria for assessing and excluding based on suicidality very likely were applied for drugs approved post-2000., Conclusions: The exclusion of persons with suicidality from antidepressant trials is common, creating uncertainty about medication safety and efficacy in parts of the target population. Information about study populations can be beneficial for prescribing clinicians, but it is not always readily available., (© Copyright 2020 Physicians Postgraduate Press, Inc.)

Study objectivesSleep disturbance is significantly associated with suicidal ideation. However, the majority of past research has examined the relationship between insomnia and suicidality. The current exploratory study examined the relationship of circadian rhythm dysregulation (eveningness, seasonality, and rhythmicity) with suicidality.MethodsWe examined the association of insomnia, eveningness, seasonality, and rhythmicity with suicidal ideation in 103 participants with depression, insomnia, and suicidality within a larger 8-week double-blinded randomized control trial primarily examining whether cautious use of zolpidem extended-release or placebo reduced suicidal ideation. All participants additionally received an open-label selective serotonin reuptake inhibitor. Methodological strengths of the current analyses included consideration of multiple sleep-wake constructs, adjustment for relevant covariates, investigation of relationships over the course of treatment, and use of both self-report measures and objective measurement with actigraphy.ResultsOver the course of treatment, self-reported eveningness and greater insomnia severity were independently correlated with greater suicidal ideation, whereas actigraphic delayed sleep timing was related to suicidal ideation at a trend level. At the end of treatment, those with greater suicidal ideation demonstrated lower actigraphic activity levels. There were no significant relationships between self-reported seasonality and actigraphic measures of sleep disturbance and suicidality.ConclusionsSelf-reported delays in sleep timing, objectively lower activity levels, and self-reported insomnia severity correlated independently with greater suicidal ideation in those with depression, insomnia, and suicidality. These exploratory findings highlight the need to consider sleep-wake constructs more broadly in those with suicidality in future research studies in order to improve more definitively both assessment and intervention efforts.Clinical trial registrationRegistry: ClinicalTrials.gov; Name: Reducing Suicidal Ideation through Insomnia Treatment; URL: https://clinicaltrials.gov/ct2/show/NCT01689909; Identifier: NCT01689909 Rumble ME, McCall MV, Dickson DA, Krystal AD, Rosenquist PB, Benca RM. An exploratory analysis of the association of circadian rhythm dysregulation and insomnia with suicidal ideation over the course of treatment in individuals with depression, insomnia, and suicidal ideation. J Clin Sleep Med. 2020;16(8):XXX-XXX.

ObjectiveThe authors sought to determine whether targeted treatment of insomnia with controlled-release zolpidem (zolpidem-CR) in suicidal adults with insomnia would provide a reduction in suicidal ideation superior to placebo.MethodsReducing Suicidal Ideation Through Insomnia Treatment was an 8-week three-site double-blind placebo-controlled parallel-group randomized controlled trial of zolpidem-CR hypnotic therapy compared with placebo, in conjunction with an open-label selective serotonin reuptake inhibitor. Participants were medication-free 18- to 65-year-olds with major depressive disorder, insomnia, and suicidal ideation. Suicidal ideation was the main outcome, measured first by the Scale for Suicide Ideation and second by the Columbia-Suicide Severity Rating Scale (C-SSRS).ResultsA total of 103 participants were randomly assigned to receive zolpidem-CR (N=51) or placebo (N=52) (64 women and 39 men; mean age=40.5 years). Zolpidem-CR had a robust anti-insomnia effect, especially in patients with the most severe insomnia symptoms. No significant treatment effect was observed on the Scale for Suicide Ideation (least squares mean estimate=-0.56, SE=0.83, 95% CI=-2.19, 1.08), but the reduction in scores was significantly positively related to improvement in insomnia after accounting for the effect of other depression symptoms. The C-SSRS indicated that zolpidem-CR had a significant treatment effect (least squares mean estimate=-0.26, SE=0.12, 95% CI=-0.50, -0.02). The advantage for zolpidem-CR in reducing suicidal ideation on the C-SSRS was greater in patients with more severe insomnia. No deaths or suicide attempts occurred.ConclusionsAlthough the results do not support the routine prescription of hypnotic medication for mitigating suicidal ideation in all depressed outpatients with insomnia, they suggest that coprescription of a hypnotic during initiation of an antidepressant may be beneficial in suicidal outpatients, especially in patients with severe insomnia.

In this paper, we report the rate of previously undiagnosed obstructive sleep apnea (OSA) in a randomized clinical trial (RCT) of suicidal patients with major depressive disorder (MDD). One hundred and twenty-five suicidal adults with MDD were recruited into a RCT. None were suspected to have OSA. Fourteen percent met diagnostic criteria for OSA. The Apnea Hypopnea Index (AHI) was predicted by increasing age, male sex, and higher Body Mass Index. However, neither the degree of daytime sleepiness nor the degree of insomnia predicted AHI severity. A high degree of suspicion is warranted for OSA in suicidal patients with MDD, and for patients with treatment-resistant depression. ClinicalTrials.gov identifier: NCT01689909.

Background and Hypothesis Insomnia occurs frequently in the clinical course of schizophrenia. A growing literature has found associations between insomnia, suicidal ideation and behavior, and psychopathology in schizophrenia. We explored associations between sleep problems, suicidal ideation, and psychopathology in a cohort of patients with first-episode psychosis. Study Design We performed a secondary analysis of data for n = 403 subjects with data from the Recovery After an Initial Schizophrenia Episode study using regression models. Study Results The prevalence of sleep problems and suicidal ideation at baseline was 57% and 15%, respectively. After controlling for potential confounders, in the study baseline sleep problems were associated with increased odds of suicidal ideation with evidence of a dose-dependent relationship (OR = 2.25, 95% CI 1.15–4.41, P =.018). Over 24 months, sleep problems at any time point were associated with an over 3-fold increased odds of concurrent suicidal ideation (OR = 3.21, 95% CI 1.45–7.14, P =.004). Subjects with persistent sleep problems were almost 14 times more likely to endorse suicidal ideation at least once over the study than those without sleep problems (OR = 13.8, 95% CI 6.5–53.4, P <.001). Sleep problems were also a predictor of higher Positive and Negative Syndrome Scale total (β = 0.13–0.22), positive (β = 0.14–0.25), and general (β = 0.16–0.27) subscale scores at baseline and multiple follow-up visits (P <.01 for each). Conclusions Sleep problems are highly prevalent and associated with suicidal ideation and greater psychopathology in first-episode psychosis. Formal assessment and treatment of insomnia appear relevant to the clinical care of patients with psychosis as a predictor of suicidal ideation and symptom severity. [ABSTRACT FROM AUTHOR]

The pupillary light reflex (PLR) is a method for measuring dynamic responses within the autonomic nervous system, and would have potential value as a point‐of‐care test in a psychiatry clinic if reproducible results could be obtained in a short period of time. We collected PLR from adult community volunteers and depressed outpatients with the purpose of demonstrating (1) that valid data could be obtained >90% of the time from both the community volunteers and the patients, and (2) that reproducible results could be obtained with repeated measurement over short periods of time. Valid data were captured for 90.3% of 76 participants, allowing for two attempts of the PLR per participant. Success rates were similar for depressed patients and community volunteers. Eighteen of these 76 participants provided repeated paired measurements after 5 and 10 min of dark adaptation, producing high correlations for maximum constriction velocity (MCV) between assay 1 and 2 (Pearson's r = 0.71, p < 0.001), but there was a significant 8% increase in velocity for MCV between assay 1 and 2 (∆ = 0.34 ± 0.59 mm/s, p < 0.05). In contrast, PLR measurements were stable when tested in a separate cohort of 21 additional participants at 10 and 15 min of dark adaptation with an MCV Pearson's correlation of r = 0.84, p < 0.001, with a nonsignificant 1% difference between the two time points. These findings indicate an acceptable rate of collecting valid and reproducible PLR data when contrasting two measurements of PLR after 10 or 15 min of dark adaptation in depressed and suicidal patients. [ABSTRACT FROM AUTHOR]

• There are multiple psychometric options for measuring suicidal ideation (SI), but little is known regarding how each of these options performs in a clinical trial. • The single "suicide item" within the hamilton rating scale for depression (HRSD) is a potential option for measuring SI within a clinical trial. • The HRSD suicide item was successful in discerning significant differences in SI in a clinical trial comparing zolpidem controlled CR versus placebo as add-on treatments to a selective serotonin reuptake inhibitor in outpatients with depression, insomnia, and SI. The REST-IT study found the addition of zolpidem-controlled release (CR) provided a significant reduction in observer-rated measurement of suicidal ideation (the Columbia Suicide Severity Rating Scale) in 103 depressed outpatients with insomnia and suicidal ideation, but without significant change in a self-report measure of suicidal ideation (the Scale for Suicide Ideation). This secondary analysis of the REST-IT data examined the suicide item of another observer-rated scale, the Hamilton Rating Scale for Depression (HRSD), further clarifying the impact of insomnia-focused treatment on suicidal ideation. This analysis established a significant advantage for zolpidem-CR compared with placebo on the HRSD suicide item. [ABSTRACT FROM AUTHOR]

In this paper, we report the rate of previously undiagnosed obstructive sleep apnea (OSA) in a randomized clinical trial (RCT) of suicidal patients with major depressive disorder (MDD). One hundred and twenty-five suicidal adults with MDD were recruited into a RCT. None were suspected to have OSA. Fourteen percent met diagnostic criteria for OSA. The Apnea Hypopnea Index (AHI) was predicted by increasing age, male sex, and higher Body Mass Index. However, neither the degree of daytime sleepiness nor the degree of insomnia predicted AHI severity. A high degree of suspicion is warranted for OSA in suicidal patients with MDD, and for patients with treatment-resistant depression. ClinicalTrials.gov identifier: NCT01689909 [ABSTRACT FROM AUTHOR]

Insomnia occurs frequently in the clinical course of schizophrenia. A growing literature has found associations between insomnia, suicidal ideation, and psychopathology in patients with schizophrenia. We explored these associations in a cross-sectional study of a large sample of patients with chronic schizophrenia in China. We hypothesized that insomnia would be associated with an increased odds of current suicidal ideation and higher current psychopathology scores. We recruited 328 inpatients with chronic schizophrenia, all of whom were prescribed psychotropics. We investigated relationships between current insomnia, suicidal ideation over the past two weeks, and current psychopathology for subjects using regression models. After controlling for multiple potential confounding factors, current insomnia was an indicator of a significant, 2.5-fold increased odds of suicidal ideation (OR = 2.56, 95% CI 1.10–5.95, p = 0.029). Insomnia was also a significant indicator of lifetime suicide attempt (OR = 1.07) as well as higher Positive and Negative Syndrome Scale total (β = 0.134, p = 0.017), positive (β = 0.154, p = 0.006) and general (β = 0.145, p = 0.010) subscale scores. Insomnia is associated with suicidal ideation, lifetime suicide attempt, and higher psychopathology scores in inpatients with chronic schizophrenia. Formal assessment of insomnia appears relevant to the clinical care of patients with schizophrenia as an indicator of suicidal thinking and behavior, depression, and symptom severity. • Insomnia was a significant indicator of suicidal ideation in schizophrenia. • Insomnia was a significant indicator of lifetime suicide attempt in schizophrenia. • Insomnia was associated with higher psychopathology scores in schizophrenia. • Assessment of insomnia is relevant to clinical care in schizophrenia. [ABSTRACT FROM AUTHOR]

• Biomarkers for suicide risk are needed, as > 25% of attempts occur within 5 minutes of the decision to commit suicide • Physiologic hyperarousal is a candidate marker of suicide risk • Physiologic hyperarousal is measured quickly and non-invasively via the pupillary light reflex. • Pupillary maximum constriction velocity was faster in suicidal versus non-suicidal depressed patients and healthy controls. The pupillary light reflex (PLR) reflects physiologic arousal, and a potential point-of-care biomarker of suicide risk. We collected data from 9 healthy controls, 6 non-suicidal depressed patients, 7 with prior suicide attempts but not presently suicidal, and 8 depressed patients who were actively suicidal. The pupillary maximum constriction velocity (MCV) was similar between the non-suicidal depressed patients and healthy controls (the "Never suicidal" group). Patients with prior attempt resembled the patients expressing active suicidal ideation (the "Ever suicidal" group). MCV was a significant predictor within a logistic regression model of participants who were "Ever suicidal" versus "Never suicidal". [ABSTRACT FROM AUTHOR]