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

Sponsor

Charite University, Berlin, Germany (Other)

Overall Status

Recruiting

CT.gov ID

NCT04404309

Collaborator

Janssen-Cilag G.m.b.H (Industry)

3,331

Enrollment

Location

Anticipated Duration (Months)

115

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Depression Depression Moderate Depression Severe Suicidal and Self-injurious Behavior Suicidal Ideation Suicide, Attempted

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 Design

Study Type:

Observational

Anticipated Enrollment :

3331 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 1, 2020

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Population 1 Any patient admitted to a psychiatric ward with a clinical diagnosis of (unipolar) major depression
Population 2 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 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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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