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  1. Article ; Online: Association of intranasal esketamine, a novel ‘standard of care’ treatment and outcomes in the management of patients with treatment-resistant depression

    Peter Giacobbe / Ayal Schaffer / Raymond W Lam / Roumen Milev / Gustavo Vazquez / Gilmar Gutierrez / Joshua Rosenblat / Jennifer Swainson / Ganapathy Karthikeyan / Nisha Ravindran / André Do / Emily Hawken

    BMJ Open, Vol 12, Iss

    protocol of a prospective cohort observational study of naturalistic clinical practice

    2022  Volume 9

    Abstract: Introduction Esketamine is the S-enantiomer of racemic ketamine and has been approved by the Food and Drug Administration for the management of treatment resistant depression, demonstrating effective and long-lasting benefits. The objective of this ... ...

    Abstract Introduction Esketamine is the S-enantiomer of racemic ketamine and has been approved by the Food and Drug Administration for the management of treatment resistant depression, demonstrating effective and long-lasting benefits. The objective of this observational study is to elucidate the association of intranasal (IN) esketamine with beneficial and negative outcomes in the management of treatment resistant major depressive disorder.Methods and analysis This is a multicentre prospective cohort observational study of naturalistic clinical practice. We expect to recruit 10 patients per research centre (6 centres, total 60 subjects). After approval to receive IN esketamine as part of their standard of care management of moderate to severe treatment resistant depression, patients will be invited to participate in this study. Association of esketamine treatment with outcomes in the management of depression will be assessed by measuring the severity of depression symptoms using the Montgomery-Åsberg Depression Rating Scale (MADRS), and tolerability by systematically tracking common side effects of ketamine treatment, dissociation using the simplified 6-Item Clinician Administered Dissociative Symptom Scale and potential for abuse using the Likeability and Craving Questionnaire (LCQ). Change in depressive symptoms (MADRS total scores) over time will be evaluated by within-subject repeated measures analysis of variance. We will calculate the relative risk associated with the beneficial (reduction in total scores for depression) outcomes, and the side effect and dropout rates (tolerability) of adding IN esketamine to patients’ current pharmacological treatments. Covariate analysis will assess the impact of site and demographic variables on treatment outcomes.Ethics and dissemination Approval to perform this study was obtained through the Health Sciences Research Ethics Board at Queen’s University. Findings will be shared among collaborators, through departmental meetings, presented on different academic venues and ...
    Keywords Medicine ; R
    Subject code 310
    Language English
    Publishing date 2022-09-01T00:00:00Z
    Publisher BMJ Publishing Group
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  2. Article ; Online: Nitrous oxide as a putative novel dual-mechanism treatment for bipolar depression

    Mikaela K. Dimick / Danielle Omrin / Bradley J. MacIntosh / Rachel H.B. Mitchell / Daniel Riegert / Anthony Levitt / Ayal Schaffer / Susan Belo / John Iazzetta / Garfield Detzler / Mabel Choi / Stephen Choi / Beverley A. Orser / Benjamin I. Goldstein

    Contemporary Clinical Trials Communications, Vol 19, Iss , Pp 100600- (2020)

    Proof-of-concept study design and methodology

    2020  

    Abstract: Introduction: Depressive symptoms predominate in the course of bipolar disorder (BD) and there is an urgent need to evaluate novel application of repurposed compounds that act on pre-specified treatment targets. Several lines of reasoning suggest that ... ...

    Abstract Introduction: Depressive symptoms predominate in the course of bipolar disorder (BD) and there is an urgent need to evaluate novel application of repurposed compounds that act on pre-specified treatment targets. Several lines of reasoning suggest that nitrous oxide (N2O) is an ideal medication to study as a potential treatment and as a strategy to identify the underlying pathophysiology of bipolar depression. N2O is a potent cerebral vasodilator and there is compelling evidence of reduced frontal cerebral blood flow (CBF; i.e. hypoperfusion) in depression. Therefore, N2O may increase CBF and thereby improve symptoms of depression. The goal of this randomized, double-blind trial is to study the effect of a single administration of N2O versus the active comparator midazolam on mood and CBF in adults with treatment-resistant bipolar depression. Methods: Participants with BD-I/-II currently experiencing a major depressive episode will be randomized to one of two conditions (n = 20/group): 1) inhaled N2O plus intravenous saline, or 2) inhaled room air plus intravenous midazolam. Montgomery-Asberg Depression Rating Scale scores will serve as the primary endpoint. CBF will be measured via arterial spin labelling magnetic resonance imaging. Conclusions: N2O is a potential novel treatment for bipolar depression, as it causes cerebral vasodilation. This proof-of-concept study will provide valuable information regarding the acute impact of N2O on mood and on CBF. If N2O proves to be efficacious in future larger-scale trials, its ubiquity, safety, low cost, and ease of use suggest that it has great potential to become a game-changing acute treatment for bipolar depression.
    Keywords Nitrous oxide ; Bipolar depression ; Novel therapeutics ; Cerebral blood flow ; Medicine (General) ; R5-920
    Subject code 150 ; 610
    Language English
    Publishing date 2020-09-01T00:00:00Z
    Publisher Elsevier
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  3. Article ; Online: Association of Weekly Suicide Rates with Temperature Anomalies in Two Different Climate Types

    P. Grady Dixon / Mark Sinyor / Ayal Schaffer / Anthony Levitt / Christa R. Haney / Kelsey N. Ellis / Scott C. Sheridan

    International Journal of Environmental Research and Public Health, Vol 11, Iss 11, Pp 11627-

    2014  Volume 11644

    Abstract: Annual suicide deaths outnumber the total deaths from homicide and war combined. Suicide is a complex behavioral endpoint, and a simple cause-and-effect model seems highly unlikely, but relationships with weather could yield important insight into the ... ...

    Abstract Annual suicide deaths outnumber the total deaths from homicide and war combined. Suicide is a complex behavioral endpoint, and a simple cause-and-effect model seems highly unlikely, but relationships with weather could yield important insight into the biopsychosocial mechanisms involved in suicide deaths. This study has been designed to test for a relationship between air temperature and suicide frequency that is consistent enough to offer some predictive abilities. Weekly suicide death totals and anomalies from Toronto, Ontario, Canada (1986–2009) and Jackson, Mississippi, USA (1980–2006) are analyzed for relationships by using temperature anomaly data and a distributed lag nonlinear model. For both analysis methods, anomalously cool weeks show low probabilities of experiencing high-end suicide totals while warmer weeks are more likely to experience high-end suicide totals. This result is consistent for Toronto and Jackson. Weekly suicide totals demonstrate a sufficient association with temperature anomalies to allow some prediction of weeks with or without increased suicide frequency. While this finding alone is unlikely to have immediate clinical implications, these results are an important step toward clarifying the biopsychosocial mechanisms of suicidal behavior through a more nuanced understanding of the relationship between temperature and suicide.
    Keywords suicide ; climate ; meteorology ; Canada ; Mississippi ; temperature ; weather ; Medicine ; R
    Subject code 310
    Language English
    Publishing date 2014-11-01T00:00:00Z
    Publisher MDPI AG
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  4. Article ; Online: The BEACON study

    Simon Hatcher / Marnin Heisel / Oyedeji Ayonrinde / Julie K. Campbell / Ian Colman / Daniel J. Corsi / Nicole E. Edgar / Lindsay Gillett / Sidney H. Kennedy / Sophia Lakatoo Hunt / Paul Links / Sarah MacLean / Viraj Mehta / Christopher Mushquash / Alicia Raimundo / Sakina J. Rizvi / Refik Saskin / Ayal Schaffer / Alaaddin Sidahmed /
    Mark Sinyor / Claudio Soares / Monica Taljaard / Valerie Testa / Kednapa Thavorn / Venkatesh Thiruganasambandamoorthy / Christian Vaillancourt

    Trials, Vol 21, Iss 1, Pp 1-

    protocol for a cohort study as part of an evaluation of the effectiveness of smartphone-assisted problem-solving therapy in men who present with intentional self-harm to emergency departments in Ontario

    2020  Volume 16

    Abstract: Abstract Background Patients who present to emergency departments after intentional self-harm are at an increased risk of dying by suicide. This applies particularly to men, who represent nearly two-thirds of those who die by suicide in Ontario. One way ... ...

    Abstract Abstract Background Patients who present to emergency departments after intentional self-harm are at an increased risk of dying by suicide. This applies particularly to men, who represent nearly two-thirds of those who die by suicide in Ontario. One way of potentially addressing this gap is to offer a course of blended problem-solving therapy, comprised of a brief course of evidence-based psychotherapy for individuals at risk for suicide, facilitated by the use of a patient-facing smartphone application and a clinician-facing “dashboard.” This approach has the potential to combine the benefits of face-to-face therapy and technology to create a novel intervention. Methods This is a cohort study nested within a larger pragmatic multicentre pre- and post-design cluster randomised trial. Suicidal ideation assessed by the Beck Scale for Suicide Ideation is the primary outcome variable. Secondary outcome measures include depression (Patient Health Questionnaire-9), anxiety (Generalized Anxiety Disorder 7-item scale), post-traumatic stress disorder (Primary Care PTSD Screen), health-related quality of life (EuroQol 5-dimension 5-level questionnaire), meaning in life (Experienced Meaning in Life Scale), perceived social supports (Multidimensional Scale of Perceived Social Support), alcohol use (Alcohol Use Disorders Identification Test), drug use (Drug Abuse Screening Test Short Form 10), problem-solving skills (Social Problem-Solving Inventory–Revised Short Form), and self-reported healthcare costs, as well as health service use measured using Ontario administrative health data. A process evaluation will also be conducted following study completion. Discussion The cohort study will test whether better adherence to the intervention results in better outcomes. The value of the cohort study design is that we can examine in more detail certain subgroups or other variables that are not available in the larger cluster randomised trial. This trial will aim to improve standards by informing best practice in management of men who self-harm and present to hospitals in Ontario. Trial registration ClinicalTrials.gov , NCT03473535 . Registered on March 22, 2018.
    Keywords Self-harm ; Suicide ; Problem-solving therapy ; Blended care ; Cognitive behaviour therapy ; Men ; Medicine (General) ; R5-920
    Subject code 360
    Language English
    Publishing date 2020-11-01T00:00:00Z
    Publisher BMC
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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