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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    3331
  • sponsor
    Charite University, Berlin, Germany
Updated on 27 May 2021
depression
depressive disorder
depressive symptoms
depressed mood
depressive episode
suicidal

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.

Details
Condition Depression Moderate, Depression (Adolescent), Severe Depression, depressed mood, miserable, Suicidal and Self-injurious Behavior, Endogenous depression, Moderate Depression, Suicidal Ideation, Suicide attempt, Suicide, Depression (Adult and Geriatric), Depression, depressive disorders, Depression Severe, depressive disorder, Depression (Treatment-Resistant), Depression (Pediatric), Depression (Major/Severe), Depressed
Clinical Study IdentifierNCT04404309
SponsorCharite University, Berlin, Germany
Last Modified on27 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 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
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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