Outcomes Associated With Suicidality in Inpatients With Symptoms of Depression (OASIS-D)

Study Overview
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Brief Summary
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This 6-month, naturalistic cohort study examines male and female inpatients aged 18 to 75 years i) with any form of unipolar depressive episode (cohort 1); ii) clinical diagnosis of a moderate or severe unipolar depressive episode and suicidal tendencies who agree to participate in a prospective study (cohort 2); and moderate or severe unipolar depressive episodes validated by research interviews and and suicidal tendencies that persist for at least 48 hours after admission who are followed up for 6 months (cohort 3).

Detailed Description
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Epidemiological cross-sectional study in over 3000 inpatients with a clinical diagnosis of major depressive disorder, validation of the clinical diagnosis in 520 patients, and prospective naturalistic 6-month follow-up study of 260 adults with a research interview-confirmed major depressive disorder, with data collection at the following points: at T0 = time of hospitalization (epidemiological study population 1 with data from clinical routine practice), at time T1 of baseline survey in patients with persistent suicidal tendencies, i.e. at least 48 hours after T0 (study population 2 as a subgroup of study population 1, with study information and consent), and in study population 3 (subgroup of study population 2, with study information and consent) at the time of discharge (T2), 3 months after admission to hospital (T3/ by telephone) and 6 months after inpatient admission (T4). The aim of the study is to characterize the remission or recurrence of suicidal symptoms in the context of a depressive episode. It is expected that the results will help to improve the understanding of the disease process and the further development of effective intervention options.

Official Title
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Patient Characteristics, Validity of Clinical Diagnoses and Outcomes Associated With Suicidality in Inpatients With Symptoms of Depression (OASIS-D)

Conditions
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Depression, Depression Moderate, Depression Severe, Suicidal and Self-injurious Behavior, Suicidal Ideation, Suicide, Attempted

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For Population 1 1.any form of unipolar depressive episode For Population 2 clinical diagnosis of a moderate or severe unipolar depressive episode clinically diagnosed suicidal tendencies that persist for at least 48 hours after admission to hospital Written consent to participate in the study For Population 3 Diagnosis of a moderate or severe unipolar depressive disorder through the structured research interview Mini International Neuropsychiatric Interview (M.I.N.I.) Suicidality with a value > / = 1 for item 2 (passive suicidality) OR item 3 (active suicidality) based on the research interview Sheehan Suicidality Tracking Scale (S-STS) Written consent to participate in the study Exclusion Criteria: Patients younger than 18 years or older than 75 years No clinical diagnosis of a depressive episode Depressive episode in the context of a bipolar disorder- secondary depression as a result of physical illness or substance use severe physical symptoms of disease that make participation in the study impossible Pregnancy not being able to understand the study processes incapable of giving informed consent no authorization to give consent due to (limited) incapacity

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Population 1<br>Any patient admitted to a psychiatric ward with a clinical diagnosis of (unipolar) major depression | |
| Population 2<br>Any patient with a clinical diagnosis of a moderate or severe unipolar depressive disorder with suicidal tendencies that persist for at least 48 hours after admission | |
| Population 3<br>Patients with moderate or severe unipolar depressive episodes validated by research interviews and suicidal tendencies that persist for at least 48 hours after admission who will be followed up for 6 months | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sheehan Suicidality Tracking Scale (S-STS) | Interview for Suicidality, Suicidal Behavior and Suicide Attempts, the higher the value the worse the outcome, the values can range from 0- 156 | 20 min | 
| Mini-International Neuropsychiatric Interview (M.I.N.I.) | Semi-structured interview for research diagnosis | 40 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression of Resolution Suicide Risk (CGI-SR-R) | One Question rated by an interviewer | 1 min | 
| Clinical Global Impression of Imminent Suicide Risk (CGI-SR-I) | One Question rated by an interviewer | 1 min | 
| Clinical Global Impression - Severity (CGI-S) | One Question about severity of illness, rated by an interviewer | 1 min | 
| Clinical Global Impression - Change (CGI-C) | One Question about change of the symptoms rated by an interviewer | 1 min | 
| Young Mania Rating Scale (YMRS) | Structured Interview for Mania Symptoms | 20 min | 
| Montgomery-Asberg Depression Rating Scale (MADRS) | Structured Interview for Symptoms of Depression | 20 min | 
| Service Use and Resource Form (SURF) | Structured Interview for Service Use of the health care system | 30 min | 
| Adherence Questions | Semi Structured Interview for Adherence of Antipsychotics | 5 min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Suicidality