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

NCT04404309 | Recruiting DMC

• 1 other identifier: EA2/061/20
• Study Type: observational
• Target: 3,331
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

Depression; Suicidality

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Clinical Global Impression of Resolution Suicide Risk (CGI-SR-R)

  1 min

• Clinical Global Impression of Imminent Suicide Risk (CGI-SR-I)

  1 min

• Clinical Global Impression - Severity (CGI-S)

  1 min

• Clinical Global Impression - Change (CGI-C)

  1 min

• Young Mania Rating Scale (YMRS)

  20 min

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• For Population 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Janssen-Cilag G.m.b.H: collaborator

Study Sites (1)

Charité

Mitte, Germany

RECRUITING

Related Publications (2)

• Nohles VB, Bermpohl F, Schoofs N, Bathe-Peters R, Hilpert N, Dafsari FS, Reif-Leonhard C, Reif A, Schillo S, Arshad RS, Getty P, Falkai P, Schule C, Wang E, Adli M, Papenfuss R, Meyer-Lindenberg A, Fritze S, Otte C, Piber D, Graumann L, Weyn-Banningh S, Bauer M, Lewitzka U, Spreer M, Clemens J, Rubarth K, Correll CU. Clinical and Treatment Characteristics of 3795 Adults Consecutively Hospitalized for Major Depressive Disorder in the OASIS-D Study. Depress Anxiety. 2025 Nov 26;2025:4470169. doi: 10.1155/da/4470169. eCollection 2025.

  PMID: 41347111 DERIVED

• 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.

  PMID: 37828493 DERIVED

MeSH Terms

Conditions

Depression; Self-Injurious Behavior; Suicidal Ideation; Suicide, Attempted

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Suicide

Study Officials

• Christoph U Correll, MD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christoph U Correll, MD

CONTACT

+49-30-450; christoph.correll@charite.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinic Director

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: May 27, 2020
• Study Start: August 1, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

DE (1)