Examining outcomes related to suicidality in hospitalized patients with depression
Patient Characteristics, Validity of Clinical Diagnoses and Outcomes Associated With Suicidality in Inpatients With Symptoms of Depression (OASIS-D)
This study is trying to understand how suicidal thoughts change over time in hospitalized patients with depression to help improve their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3331 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Charite University, Berlin, Germany Academic / other |
| Locations | 1 site (Berlin-Mitte) |
| Trial ID | NCT04404309 on ClinicalTrials.gov |
What this trial studies
This observational cohort study investigates the outcomes associated with suicidality in inpatients aged 18 to 75 years who are experiencing unipolar depressive episodes. It includes three cohorts: those with any form of unipolar depression, those with moderate to severe depression and suicidal tendencies, and those with persistent suicidal tendencies after 48 hours of hospitalization. The study aims to collect data at multiple time points over a 6-month period to better understand the remission or recurrence of suicidal symptoms in the context of depression. The findings are expected to inform future interventions and improve treatment strategies for affected individuals.
Who should consider this trial
Good fit: Ideal candidates are inpatients aged 18 to 75 with a clinical diagnosis of unipolar depression, particularly those exhibiting suicidal tendencies.
Not a fit: Patients with depressive episodes related to bipolar disorder or secondary causes, as well as those outside the age range of 18 to 75, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of suicidal behavior in depressed patients, leading to improved treatment options.
How similar studies have performed: Other studies have explored similar themes regarding suicidality in depression, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Berlin-Mitte
- Charité — Berlin-Mitte, Germany (Recruiting)
Study contacts
- Principal investigator: Christoph U Correll, MD — Charite University, Berlin, Germany
- Study coordinator: Christoph U Correll, MD
- Email: christoph.correll@charite.de
- Phone: +49-30-450
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.