Patient characteristics, validity of clinical diagnoses and Outcomes Associated with Suicidality in Inpatients with Symptoms of Depression (OASIS-D): design, procedures and outcomes

BMC Psychiatry

Study Protocol

Peter Falkai¹  Ion-George Anghelescu²  Viktor B. Nöhles³  Christoph U. Correll⁴  Andreas Meyer-Lindenberg⁵  Christian Otte⁶  Mazda Adli⁷  Felix Bermpohl⁸  Dan Rujescu⁹  Michael Bauer^1,10  Frank Jessen^1,11  Christine Reif-Leonhard^1,12  Kerstin Rubarth^1,13 

[1] Clinic for Psychiatry and Psychotherapy, Ludwig-Maximilians-University Munich, Munich, Germany;Clinic for Psychiatry, Psychosomatics and Psychotherapy, Mental Health Institute Berlin, Berlin, Germany;Department of Child and Adolescent Psychiatry, Charité Universitätsmedizin – Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Augustenburger Platz 1, 13353, Berlin, Germany;Department of Child and Adolescent Psychiatry, Charité Universitätsmedizin – Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Augustenburger Platz 1, 13353, Berlin, Germany;Psychiatry Research, The Zucker Hillside Hospital, Northwell Health, Glen Oaks, NY, USA;Department of Psychiatry and Molecular Medicine, Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA;Department of Psychiatry and Psychotherapy, Central Institute of Mental Health, Mannheim, Germany;Department of Psychiatry and Psychotherapy, Charité Universitätsmedizin - Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Campus Benjamin Franklin, Berlin, Germany;Department of Psychiatry and Psychotherapy, Charité Universitätsmedizin – Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Campus Mitte, Berlin, Germany;Center for Psychiatry, Psychotherapy and Psychosomatic Medicine, Fliedner Klinik Berlin, Berlin, Germany;Department of Psychiatry and Psychotherapy, Charité Universitätsmedizin – Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Campus St. Hedwig Hospital, Berlin, Germany;Department of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria;Department of Psychiatry and Psychotherapy, University Hospital Carl Gustav Carus, Dresden, Germany;Department of Psychiatry and Psychotherapy, University of Cologne, Cologne, Germany;Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital Frankfurt, Frankfurt am Main, Germany;Institute of Medical Informatics, Charité Universitätsmedizin – Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany;Institute of Biometry and Clinical Epidemiology, Charité Universitätsmedizin – Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany;

关键词: Depression;    Suicidality;    Observational study;    Treatment;    Correlates;    Diagnostic agreement;    Moderators;    Mediators;   

DOI  :  10.1186/s12888-023-05230-9

 received in 2023-06-15, accepted in 2023-09-28,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundSuicidality, ranging from passive suicidal thoughts to suicide attempt, is common in major depressive disorder (MDD). However, relatively little is known about patient, illness and treatment characteristics in those with co-occurring MDD and suicidality, including the timing of and factors associated with the offset, continuation or reemergence of suicidality. Here, we present the background, rationale, design and hypotheses of the Patient Characteristics, Validity of Clinical Diagnoses and Outcomes Associated with Suicidality in Inpatients with Symptoms of Depression (OASIS-D) study, an investigator-initiated, observational study, funded by Janssen-Cilag GmbH.Methods/ResultsOASIS-D is an eight-site, six-month, cohort study of patients aged 18-75 hospitalized with MDD. Divided into three sub-studies and patient populations (PPs), OASIS-D will (i) systematically characterize approximately 4500 consecutively hospitalized patients with any form of unipolar depressive episode (PP1), (ii) evaluate the validity of the clinical diagnosis of moderate or severe unipolar depressive episode with the Mini-International Neuropsychiatric Interview (M.I.N.I.) and present suicidality (at least passive suicidal thoughts) present ≥ 48 h after admission with the Sheehan-Suicide Tracking Scale (S-STS), assessing also predictors of the diagnostic concordance/discordance of MDD in around 500 inpatients (PP2), and (iii) characterize and prospectively follow for 6 months 315 inpatients with a research-verified moderate or severe unipolar depressive episode and at least passive suicidal thoughts ≥ 48 h after admission, evaluating treatment and illness/response patterns at baseline, hospital discharge, 3 and 6 months. Exploratory objectives will describe the association between the number of days with suicidality and utilization of outpatient and inpatient care services, and structured assessments of factors influencing the risk of self-injurious behavior without suicidal intent, and of continuous, intermittent or remitted suicidality during the 6-month observation period.ConclusionDespite their frequency and clinical relevance, relatively little is known about patient and treatment characteristics of individuals with MDD and suicidality, including factors moderating and mediating the outcome of both MDD and suicidality. Results of the OASIS-D study are hoped to improve the understanding of the frequency, correlates and 6-month naturalistic treatment and outcome trajectories of different levels of suicidality in hospitalized adults with MDD and suicidality.Trial registrationNCT04404309 [ClinicalTrials.gov]

【 授权许可】

CC BY   
© BioMed Central Ltd., part of Springer Nature 2023

【 图 表 】

Fig. 1