Patient characteristics, validity of clinical diagnoses and Outcomes Associated with Suicidality in Inpatients with Symptoms of Depression (OASIS-D): design, procedures and outcomes
Abstract Background Suicidality, 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 a...
| Main Authors: | , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2023-10-01
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| Series: | BMC Psychiatry |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12888-023-05230-9 |
| _version_ | 1827633467928608768 |
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| author | Viktor B. Nöhles Felix Bermpohl Peter Falkai Christine Reif-Leonhard Frank Jessen Mazda Adli Christian Otte Andreas Meyer-Lindenberg Michael Bauer Kerstin Rubarth Ion-George Anghelescu Dan Rujescu Christoph U. Correll |
| author_facet | Viktor B. Nöhles Felix Bermpohl Peter Falkai Christine Reif-Leonhard Frank Jessen Mazda Adli Christian Otte Andreas Meyer-Lindenberg Michael Bauer Kerstin Rubarth Ion-George Anghelescu Dan Rujescu Christoph U. Correll |
| author_sort | Viktor B. Nöhles |
| collection | DOAJ |
| description | Abstract Background Suicidality, 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/Results OASIS-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. Conclusion Despite 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 registration NCT04404309 [ClinicalTrials.gov] |
| first_indexed | 2024-03-09T14:59:53Z |
| format | Article |
| id | doaj.art-4f59fd1d287e4c0da94e3e0da9dbe5b7 |
| institution | Directory Open Access Journal |
| issn | 1471-244X |
| language | English |
| last_indexed | 2024-03-09T14:59:53Z |
| publishDate | 2023-10-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Psychiatry |
| spelling | doaj.art-4f59fd1d287e4c0da94e3e0da9dbe5b72023-11-26T13:57:13ZengBMCBMC Psychiatry1471-244X2023-10-0123111610.1186/s12888-023-05230-9Patient characteristics, validity of clinical diagnoses and Outcomes Associated with Suicidality in Inpatients with Symptoms of Depression (OASIS-D): design, procedures and outcomesViktor B. Nöhles0Felix Bermpohl1Peter Falkai2Christine Reif-Leonhard3Frank Jessen4Mazda Adli5Christian Otte6Andreas Meyer-Lindenberg7Michael Bauer8Kerstin Rubarth9Ion-George Anghelescu10Dan Rujescu11Christoph U. Correll12Department of Child and Adolescent Psychiatry, Charité Universitätsmedizin – Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu BerlinDepartment of Psychiatry and Psychotherapy, Charité Universitätsmedizin – Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu BerlinClinic for Psychiatry and Psychotherapy, Ludwig-Maximilians-University MunichDepartment of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital FrankfurtDepartment of Psychiatry and Psychotherapy, University of CologneDepartment of Psychiatry and Psychotherapy, Charité Universitätsmedizin – Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Campus MitteDepartment of Psychiatry and Psychotherapy, Charité Universitätsmedizin - Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Campus Benjamin FranklinDepartment of Psychiatry and Psychotherapy, Central Institute of Mental HealthDepartment of Psychiatry and Psychotherapy, University Hospital Carl Gustav CarusInstitute of Medical Informatics, Charité Universitätsmedizin – Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu BerlinClinic for Psychiatry, Psychosomatics and Psychotherapy, Mental Health Institute BerlinDepartment of Psychiatry and Psychotherapy, Medical University of ViennaDepartment of Child and Adolescent Psychiatry, Charité Universitätsmedizin – Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu BerlinAbstract Background Suicidality, 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/Results OASIS-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. Conclusion Despite 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 registration NCT04404309 [ClinicalTrials.gov]https://doi.org/10.1186/s12888-023-05230-9DepressionSuicidalityObservational studyTreatmentCorrelatesDiagnostic agreement |
| spellingShingle | Viktor B. Nöhles Felix Bermpohl Peter Falkai Christine Reif-Leonhard Frank Jessen Mazda Adli Christian Otte Andreas Meyer-Lindenberg Michael Bauer Kerstin Rubarth Ion-George Anghelescu Dan Rujescu Christoph U. Correll 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 Depression Suicidality Observational study Treatment Correlates Diagnostic agreement |
| title | Patient characteristics, validity of clinical diagnoses and Outcomes Associated with Suicidality in Inpatients with Symptoms of Depression (OASIS-D): design, procedures and outcomes |
| title_full | Patient characteristics, validity of clinical diagnoses and Outcomes Associated with Suicidality in Inpatients with Symptoms of Depression (OASIS-D): design, procedures and outcomes |
| title_fullStr | Patient characteristics, validity of clinical diagnoses and Outcomes Associated with Suicidality in Inpatients with Symptoms of Depression (OASIS-D): design, procedures and outcomes |
| title_full_unstemmed | Patient characteristics, validity of clinical diagnoses and Outcomes Associated with Suicidality in Inpatients with Symptoms of Depression (OASIS-D): design, procedures and outcomes |
| title_short | Patient characteristics, validity of clinical diagnoses and Outcomes Associated with Suicidality in Inpatients with Symptoms of Depression (OASIS-D): design, procedures and outcomes |
| title_sort | patient characteristics validity of clinical diagnoses and outcomes associated with suicidality in inpatients with symptoms of depression oasis d design procedures and outcomes |
| topic | Depression Suicidality Observational study Treatment Correlates Diagnostic agreement |
| url | https://doi.org/10.1186/s12888-023-05230-9 |
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