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

NCT ID: NCT04404309

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 3331 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2024-12-31

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Population 1

Any patient admitted to a psychiatric ward with a clinical diagnosis of (unipolar) major depression

No interventions assigned to this group

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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen-Cilag G.m.b.H

INDUSTRY

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. med Christoph Correll

Clinic Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christoph U Correll, MD

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

Charité

Mitte, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Christoph U Correll, MD

Role: CONTACT

christoph.correll@charite.de

+49-30-450 ext. 566202

Facility Contacts

Fabiola Heuer

Role: primary

References

Nohles VB, Bermpohl F, Falkai P, Reif-Leonhard C, Jessen F, Adli M, Otte C, Meyer-Lindenberg A, Bauer M, Rubarth K, Anghelescu IG, Rujescu D, Correll CU. Patient characteristics, validity of clinical diagnoses and Outcomes Associated with Suicidality in Inpatients with Symptoms of Depression (OASIS-D): design, procedures and outcomes. BMC Psychiatry. 2023 Oct 13;23(1):744. doi: 10.1186/s12888-023-05230-9.

Reference Type: DERIVED

PMID: 37828493 (View on PubMed)

Other Identifiers

EA2/061/20

Identifier Type: -

Identifier Source: org_study_id