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

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

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).

Study Overview

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

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 Type: Observational
• Enrollment (Estimated): 3331

Contacts and Locations

• Study Contact: Name: Christoph U Correll, MD; Phone Number: 566202 +49-30-450; Email: christoph.correll@charite.de

Study Locations

• Germany
  • Berlin-Mitte, Germany
    • Recruiting
    • Charité
    • Contact: Fabiola Heuer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patient are gonna be recruited from 7 different psychiatric clinics. For population 1, only clinically available data is extracted from patient records population 2 and 3: Patients who meet the inclusion criteria and are in psychiatric hospital treatment in the study centres

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Collaborators: Janssen-Cilag G.m.b.H
• Investigators: Principal Investigator: Christoph U Correll, MD, Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: May 22, 2020
• First Submitted That Met QC Criteria: May 26, 2020
• First Posted (Actual): May 27, 2020

Study Record Updates

• Last Update Posted (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Depression; Suicidality
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Suicide; Suicidal Ideation; Suicide, Attempted; Self-Injurious Behavior
• Other Study ID Numbers: EA2/061/20

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No