DepressionOASIS-DNCT04404309
Outcomes Associated With Suicidality in Inpatients With Symptoms of Depression (OASIS-D)
An observational study of Depression and Depression Moderate, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Depression, Depression Moderate, Depression Severe
- How many people
- 3,331 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2020to 31 Dec 2024
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- For Population 1
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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
- Keywords
- Depression, Suicidality
- Medical subject headings
- Depression, Self-Injurious Behavior, Suicidal Ideation, Suicide, Attempted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 20 min
Mini-International Neuropsychiatric Interview (M.I.N.I.)
Semi-structured interview for research diagnosis
Measured: 40 min
Secondary outcomes (8)
Clinical Global Impression of Resolution Suicide Risk (CGI-SR-R)
One Question rated by an interviewer
Measured: 1 min
Clinical Global Impression of Imminent Suicide Risk (CGI-SR-I)
One Question rated by an interviewer
Measured: 1 min
Clinical Global Impression - Severity (CGI-S)
One Question about severity of illness, rated by an interviewer
Measured: 1 min
Clinical Global Impression - Change (CGI-C)
One Question about change of the symptoms rated by an interviewer
Measured: 1 min
Young Mania Rating Scale (YMRS)
Structured Interview for Mania Symptoms
Measured: 20 min
Montgomery-Asberg Depression Rating Scale (MADRS)
Structured Interview for Symptoms of Depression
Measured: 20 min
Service Use and Resource Form (SURF)
Structured Interview for Service Use of the health care system
Measured: 30 min
Adherence Questions
Semi Structured Interview for Adherence of Antipsychotics
Measured: 5 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start1 Aug 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,331 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen-Cilag G.m.b.H
- Responsible party
- Principal investigator, Prof. Dr. med Christoph Correll, Charite University, Berlin, Germany
- Investigators
- Christoph U Correll, MD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04404309
- Sponsor's protocol ID
- EA2/061/20
- Acronym
- OASIS-D
- Status last verified
- Feb 2024
- First submitted
- 22 May 2020
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41347111Nohles 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.
PubMed 37828493