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

Depression Clinical Trial

— OASIS-D  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04404309
• Other study ID #: EA2/061/20
• Status: Recruiting
• Start date: August 1, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Charite University, Berlin, Germany
• Contact: Christoph U Correll, MD
• Phone: +49-30-450
• Email: christoph.correll[@]charite.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3331
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depression Moderate
• Depression Severe
• Depressive Disorder
• Self-Injurious Behavior
• Suicidal and Self-injurious Behavior
• Suicidal Ideation
• Suicide
• Suicide, Attempted

Locations

Country	Name	City	State
Germany	Charité	Berlin-Mitte

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Janssen-Cilag G.m.b.H

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Mini-International Neuropsychiatric Interview (M.I.N.I.)	Semi-structured interview for research diagnosis	40 min
Secondary	Clinical Global Impression of Resolution Suicide Risk (CGI-SR-R)	One Question rated by an interviewer	1 min
Secondary	Clinical Global Impression of Imminent Suicide Risk (CGI-SR-I)	One Question rated by an interviewer	1 min
Secondary	Clinical Global Impression - Severity (CGI-S)	One Question about severity of illness, rated by an interviewer	1 min
Secondary	Clinical Global Impression - Change (CGI-C)	One Question about change of the symptoms rated by an interviewer	1 min
Secondary	Young Mania Rating Scale (YMRS)	Structured Interview for Mania Symptoms	20 min
Secondary	Montgomery-Asberg Depression Rating Scale (MADRS)	Structured Interview for Symptoms of Depression	20 min
Secondary	Service Use and Resource Form (SURF)	Structured Interview for Service Use of the health care system	30 min
Secondary	Adherence Questions	Semi Structured Interview for Adherence of Antipsychotics	5 min