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

Recruiting

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

• Registration Number: NCT04404309
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-05-22
• Study First Submitted QC: 2020-05-26
• Study First Posted: 2020-05-27
• Study Start: 2020-08-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-07
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3331

Inclusion Criteria

For Population 1

1.any form of unipolar depressive episode

For Population 2

1. clinical diagnosis of a moderate or severe unipolar depressive episode
2. clinically diagnosed suicidal tendencies that persist for at least 48 hours after admission to hospital
3. Written consent to participate in the study

For Population 3

1. Diagnosis of a moderate or severe unipolar depressive disorder through the structured research interview "Mini International Neuropsychiatric Interview" (M.I.N.I.)
2. 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)
3. 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Charité; 🇩🇪 Berlin-Mitte, Germany