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Objective To determine the risk of neuropsychiatric adverse events associated with use of varenicline compared with placebo in randomised controlled trials.Design Systematic review and meta-analysis comparing study effects using two summary estimates in fixed effects models, risk differences, and Peto odds ratios.Data sources Medline, Embase, PsycINFO, the Cochrane Central Register of Controlled Trials (CENTRAL), and clinicaltrials.gov.Eligibility criteria for selecting studies Randomised controlled trials with a placebo comparison group that reported on neuropsychiatric adverse events (depression, suicidal ideation, suicide attempt, suicide, insomnia, sleep disorders, abnormal dreams, somnolence, fatigue, anxiety) and death. Studies that did not involve human participants, did not use the maximum recommended dose of varenicline (1 mg twice daily), and were cross over trials were excluded.Results In the 39 randomised controlled trials (10 761 participants), there was no evidence of an increased risk of suicide or attempted suicide (odds ratio 1.67, 95% confidence interval 0.33 to 8.57), suicidal ideation (0.58, 0.28 to 1.20), depression (0.96, 0.75 to 1.22), irritability (0.98, 0.81 to 1.17), aggression (0.91, 0.52 to 1.59), or death (1.05, 0.47 to 2.38) in the varenicline users compared with placebo users. Varenicline was associated with an increased risk of sleep disorders (1.63, 1.29 to 2.07), insomnia (1.56, 1.36 to 1.78), abnormal dreams (2.38, 2.05 to 2.77), and fatigue (1.28, 1.06 to 1.55) but a reduced risk of anxiety (0.75, 0.61 to 0.93). Similar findings were observed when risk differences were reported. There was no evidence for a variation in depression and suicidal ideation by age group, sex, ethnicity, smoking status, presence or absence of psychiatric illness, and type of study sponsor (that is, pharmaceutical industry or other).Conclusions This meta-analysis found no evidence of an increased risk of suicide or attempted suicide, suicidal ideation, depression, or death with varenicline. These findings provide some reassurance for users and prescribers regarding the neuropsychiatric safety of varenicline. There was evidence that varenicline was associated with a higher risk of sleep problems such as insomnia and abnormal dreams. These side effects, however, are already well recognised.Systematic review registration PROSPERO 2014:CRD42014009224.

Background Despite increasing investment in suicide prevention, Australian suicide rates have increased steadily in the past decade. In response to growing evidence for multicomponent intervention models for reducing suicide, the LifeSpan model has been developed as the first multicomponent, evidence-based, system-wide approach to suicide prevention in Australia. The LifeSpan model consists of nine evidence-based strategies. These include indicated, selective and universal interventions which are delivered simultaneously to community and healthcare systems over a 2-year implementation period. This study will evaluate the effectiveness of the LifeSpan model in reducing suicide attempts and suicide deaths in four geographically defined regions in New South Wales, Australia. Methods We outline the protocol for a stepped-wedge, cluster randomized controlled trial. Following a 6-month transition phase, the trial sites will move to the 2-year active implementation phase in 4-monthly intervals with evaluation extending a minimum of 24 months after establishment of the full active period. Analysis will be undertaken of the change attributable to the invention across the four sites. The primary outcome for the study is the rate of attempted suicide in the regions involved. Rate of suicide deaths within each site is a secondary outcome. Discussion If proven effective, the LifeSpan model for suicide prevention could be more widely delivered in Australian communities, providing a valuable new approach to tackle rising suicide rates. LifeSpan has the potential to significantly contribute to the mental health of Australians by improving help-seeking for suicide, facilitating early detection, and improving aftercare to reduce re-attempts. The findings from this research should also contribute to the evidence base for multilevel suicide prevention programs internationally. Trial registration Australia New Zealand Clinical Trials Register, ID: ACTRN12617000457347 . Prospectively registered on 28 March 2017. https://www.anzctr.org.au/TrialSearch.aspx#&&conditionCode=&dateOfRegistrationFrom=&interventionDescription=&interventionCodeOperator=OR&primarySponsorType=&gender=&distance=&postcode=&pageSize=20&ageGroup=&recruitmentCountryOperator=OR Protocol Version: 1.0, 31 May 2019.

Background Reducing access to lethal means (especially firearms) might prevent suicide, but counseling of at‐risk individuals about this strategy may not be routine. Among emergency department (ED) patients with suicidal ideation or attempts (SI/SA), we sought to describe home firearm access and examine ED provider assessment of access to lethal means. Methods This secondary analysis used data from the Emergency Department Safety Assessment and Follow‐up Evaluation, a three‐phase, eight‐center study of adult ED patients with SI/SA (2010–2013). Research staff surveyed participants about suicide‐related factors (including home firearms) and later reviewed the ED chart (including documented assessment of lethal means access). Results Among 1,358 patients with SI/SA, 11% (95% CI: 10–13%) reported ≥1 firearm at home; rates varied across sites (range: 6–26%) but not over time. On chart review, 50% (95% CI: 47–52%) of patients had documentation of lethal means access assessment. Frequency of documented assessment increased over study phases (40–60%, P < .001) but was not associated with state firearm ownership rates. Among the 337 (25%, 95% CI: 23–27%) patients discharged to home, 55% (95% CI: 49–60%) had no documentation of lethal means assessment; of these, 13% (95% CI: 8–19%; n = 24) actually had ≥1 firearm at home. Among all those reporting ≥1 home firearm to study staff, only half (50%, 95% CI: 42–59%) had provider documentation of assessment of lethal means access. Conclusions Among these ED patients with SI/SA, many did not have documented assessment of home access to lethal means, including patients who were discharged home and had ≥1 firearm at home.

Background Age-adjusted suicide rates have increased in the U.S. over the past 25 years. Algorithm-based methods for identifying individuals at risk for suicide based on electronic health record and claims data have been validated but few studies have evaluated implementation or effects on population-level suicide attempt rates. Methods This hybrid type I effectiveness-implementation pragmatic clinical trial will test a suicide risk identification model in behavioral health clinics at three large health systems. Local decision-makers will determine implementation specifics at each site. Clinics within each health system will be randomized to determine order of implementation. A stepped-wedge design using repeated measures pre/post-implementation maximizes statistical efficiency and power with fewer participants compared to a parallel design while allowing all clinics to participate. A pre-implementation period will serve as the baseline. The primary outcome will be the rate of suicide attempt per 1000 visits at 90- and 180-days following a behavioral health visit in which an individual was identified by the suicide risk model compared with the baseline period (no use of suicide risk model). Secondary outcomes include identification of suicide risk and recognition of individuals at risk for suicide (e.g., completed risk assessment), both compared to the baseline period. Generalized linear mixed models will be used to account for clustering within clinics and repeated measures over time, adjusting for relevant covariates to estimate the effect of the suicide risk model on outcomes. Implementation outcomes, including system-level determinants and clinician acceptance and use of the suicide risk model, will also be measured. Conclusions Few suicide risk models derived from administrative and clinical data have been tested in real world care settings. This trial will determine whether the use of such a risk model reduces suicide attempts compared to usual care. By describing important implementation factors, use of such risk models, if effective, may be accelerated for other health care systems. Trial registration ClinicalTrials.gov NCT06060535.

Depression and anxiety disorders are common mental disorders worldwide. The MANAS trial aimed to test the effectiveness of an intervention led by lay health counsellors in primary care settings to improve outcomes of people with these disorders. In this cluster randomised trial, primary care facilities in Goa, India, were assigned (1:1) by computer-generated randomised sequence to intervention or control (enhanced usual care) groups. All adults who screened positive for common mental disorders were eligible. The collaborative stepped-care intervention offered case management and psychosocial interventions, provided by a trained lay health counsellor, supplemented by antidepressant drugs by the primary care physician and supervision by a mental health specialist. The research assessor was masked. The primary outcome was recovery from common mental disorders as defined by the International Statistical Classification of Diseases and Related Health Problems—10th revision (ICD-10) at 6 months. This study is registered with ClinicalTrials.gov, number NCT00446407. 24 study clusters, with an equal proportion of public and private facilities, were randomised equally between groups. 1160 of 1360 (85%) patients in the intervention group and 1269 of 1436 (88%) in the control group completed the outcome assessment. Patients with ICD-10-confirmed common mental disorders in the intervention group were more likely to have recovered at 6 months than were those in the control group (n=620 [65·0%] vs 553 [52·9%]; risk ratio 1·22, 95% CI 1·00–1·47; risk difference=12·1%, 95% CI 1·6%–22·5%). The intervention had strong evidence of an effect in public facility attenders (369 [65·9%] vs 267 [42·5%], risk ratio 1·55, 95% CI 1·02–2·35) but no evidence for an effect in private facility attenders (251 [64·1%] vs 286 [65·9%], risk ratio 0·95, 0·74–1·22). There were three deaths and four suicide attempts in the collaborative stepped-care group and six deaths and six suicide attempts in the enhanced usual care group. None of the deaths were from suicide. A trained lay counsellor-led collaborative care intervention can lead to an improvement in recovery from CMD among patients attending public primary care facilities. The Wellcome Trust.

BackgroundAdolescents are at a heightened risk of suicide reattempts following hospital discharge, but few evidence-based interventions exist. This study evaluated the efficacy of the self-awareness of mental health (SAM) program combined with treatment as usual (TAU) versus TAU alone in reducing reattempts among high-risk adolescents.MethodsA randomized clinical trial was conducted across nine Spanish hospitals (January 2021–March 2024) with 261 adolescents (12–17 years) who had attempted suicide within the last 15 days. Participants were assigned to SAM + TAU (n=128) or TAU (n=133), with 12-month follow-up. The primary outcome was suicide reattempts within 12 months; secondary analyses examined time to reattempt and associated risk factors.ResultsAfter 12-months, no significant differences were found in reattempt rates [22.6% (SAM) versus 27.8% (TAU); OR=0.610, 95%CI (0.321–1.151), p=0.127] or time to reattempt [HR=0.606, 95%CI (0.390–1.021), p=0.060]. In SAM, attentional impulsivity emerged as a significant risk factor [HR=1.126, 95% CI (1.004–1.263), p=0.043], while nonplanning impulsivity was protective [HR=0.878, 95%CI (0.814–0.948), p<0.001]. In TAU, increased suicide risk was linked to suicidal intentionality [HR=1.341, 95%CI (1.009–1.782), p=0.044] and more prior attempts [HR=1.230, 95%CI (1.039–1.457), p=0.016]. Conversely, fewer psychiatric diagnoses emerged as a protective factor [HR=0.821, 95%CI (0.677–0.996), p=0.045].ConclusionsWhile no significant differences were found between groups, SAM identified important psychological factors influencing suicide risk. These findings provide a foundation for targeted interventions to prevent reattempts in adolescents.

Background Data on the prevalence of suicidal ideation, suicide attempts, and direct self-injurious behavior in adolescents with a migration background are scarce. There are hints that this population is at risk. The aim of the study is to investigate the epidemiology of suicidal ideation, suicide attempts, and direct self-injurious behavior in adolescents with a migration background in Germany while taking gender-specific differences into consideration. Methods A representative study with N  = 10,638 students (mean age 14.91 years, SD = .73).) in the state of Lower Saxony in Germany was conducted. In the 2014–2015 school year, 672 classes were selected by randomly sampling different school types. The participation rate was 84.1%, excluding any classes for which the director refused to provide consent. A total of 49.8% were female adolescents, and 23.3% of the participants had a migration background. Target variables were assessed with items from the Ottawa Self-Injury Inventory, the Self-Harm Behavior Questionnaire and the Self-Harm Inventory, partly adapted. Results Of all students, 7.6% had a lifetime history of suicide attempts, and 36.6% answered with a rating of at least “rarely” when asked to rate the lifetime prevalence of suicidal ideation. The 12-month prevalence of direct self-injurious behavior was 17.8%. Adolescents with a migration background showed a significantly higher prevalence of all three constructs ( p  = .006; p  < .001; p = .006). Male students with a migration background reported a significantly higher lifetime prevalence of suicide attempts (4.7% vs. 3.1%) than native males ( p  = .009). Female students with a migration background reported a significantly higher lifetime prevalence of suicide attempts (15.9% vs. 10.4%) and suicidal ideation (“often” 12.1% vs. 8.9%) than native female students (p < .001; p  = .008). Conclusion Our assessment indicates an elevated risk for suicidal behaviors in adolescents with a migration background. From research on adults, it is known that the dominant motives for suicidal behavior in migrants are associated with their migration history/situation. As suggested by Cramer and Kapusta’s (Front Psychol 8:1756, 2017) theoretical model, the Social-Ecological Framework of Theory, Assessment, and Prevention, there is a need for culturally sensitive preventions that take into account the specific reasons for suicide attempts in migrants.

BackgroundAdolescents and young adults with risk factors for opioid misuse and opioid use disorder are at elevated risk for overdose. We examined prior non-fatal overdose experiences among at-risk adolescents/young adults to inform prevention efforts.MethodsAdolescents/young adults (ages 16–30) in two US emergency departments self-reporting past year opioid misuse or opioid use plus a misuse risk factor completed a baseline survey as part of an ongoing randomised controlled trial. We describe baseline factors associated with (a) overall non-fatal overdose experiences and (b) groups based on substance(s) used during the worst overdose experience.ResultsAmong 771 participants (27.9% male), 40.7% reported a non-fatal overdose experience. Compared with those without a prior overdose experience, those with prior overdose experience(s) were less likely to be heterosexual, and more likely to report a prior suicide attempt and greater peer substance misuse. Regarding the worst overdose experience, substance(s) included: 36.6% alcohol only, 28.0% alcohol and cannabis, 22.6% alcohol with other substance(s) and 12.7% other substance(s) only (eg, opioids). Compared with the alcohol only group, the alcohol and cannabis group were younger and less likely to be heterosexual; the alcohol with other substance(s) group were older and had greater peer substance misuse; and the other substance(s) only group were more likely to be male, receive public assistance, screen positive for anxiety and less likely to be heterosexual.ConclusionsAmong at-risk adolescents/young adults, findings support the need for tailored overdose prevention efforts based on substance(s) used, with consideration of sexuality, mental health and peer substance use.Trial registration number NCT04550715.

Objective To examine the risk of suicidal behaviour within clinical trials of antidepressants in adults. Design Meta-analysis of 372 double blind randomised placebo controlled trials. Setting Drug development programmes for any indication in adults. Participants 99 231 adults assigned to antidepressants or placebo. Median age was 42 and 63.1% were women. Indications for treatment were major depression (45.6%), other depression (4.6%), other psychiatric disorders (27.6%), and non-psychiatric disorders (22.2%). Main outcome measures Suicidal behaviour (completed suicide, attempted suicide, or preparatory acts) and ideation.Results For participants with non-psychiatric indications, suicidal behaviour and ideation were extremely rare. For those with psychiatric indications, risk was associated with age. For suicidal behaviour or ideation and for suicidal behaviour only, the respective odds ratios were 1.62 (95% confidence interval 0.97 to 2.71) and 2.30 (1.04 to 5.09) for participants aged <25, 0.79 (0.64 to 0.98) and 0.87 (0.58 to 1.29) for those aged 25-64, and 0.37 (0.18 to 0.76) and 0.06 (0.01 to 0.58) for those aged ≥65. When age was modelled as a continuous variable, the odds ratio for suicidal behaviour or ideation declined at a rate of 2.6% per year of age (−3.9% to −1.3%, P=0.0001) and the odds ratio for suicidal behaviour declined at a rate of 4.6% per year of age (−7.4% to −1.8%, P=0.001).Conclusions Risk of suicidality associated with use of antidepressants is strongly age dependent. Compared with placebo, the increased risk for suicidality and suicidal behaviour among adults under 25 approaches that seen in children and adolescents. The net effect seems to be neutral on suicidal behaviour but possibly protective for suicidal ideation in adults aged 25-64 and to reduce the risk of both suicidality and suicidal behaviour in those aged ≥65.

Abstract Objective To determine the effects over one year of contacting patients by telephone one month or three months after being discharged from an emergency department for deliberate self poisoning compared with usual treatment. Design Multicentre, randomised controlled trial. Setting 13 emergency departments in the north of France. Participants 605 people discharged from an emergency department after attempted suicide by deliberate self poisoning. Intervention The intervention consisted of contacting patients by telephone at one month or three months after discharge from an emergency department for attempted suicide to evaluate the success of recommended treatment or to adjust treatment. Control patients received treatment as usual, in most cases referral back to their general practitioner. Main outcome measures The primary outcome measures were proportion of participants who reattempted suicide, number of deaths by suicide, and losses to follow-up at 13 months' follow-up. Secondary outcome measures were types and number of contacts with health care. Results On an intention to treat basis, the three groups did not differ significantly for further suicide attempts, deaths by suicide, or losses to follow-up: contact at one month (intervention 23% (34/147) v controls 30% (93/312), difference 7%, 95% confidence interval − 2% to 15%), three months (25% (36/146) v 30%, difference 5%, − 4% to 14%). Participants contacted at one month were less likely at follow-up to report having reattempted suicide (12% v 22% in control group, difference 10%, 2% to 18%). Conclusion Contacting people by telephone one month after being discharged from an emergency department for deliberate self poisoning may help reduce the number of reattempted suicides over one year.