Status:
RECRUITING
Outcomes Associated With Suicidality in Inpatients With Symptoms of Depression (OASIS-D)
Lead Sponsor:
Charite University, Berlin, Germany
Collaborating Sponsors:
Janssen-Cilag G.m.b.H
Conditions:
Depression
Depression Moderate
Eligibility:
All Genders
18-75 years
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 seve...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
3331 Patients enrolled
Trial Details
Trial ID
NCT04404309
Start Date
August 1 2020
End Date
December 31 2024
Last Update
February 7 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Charité
Mitte, Germany