Autor:innen:
Christoph U. Correll, Berlin (Germany)
Mazda Adli, Berlin (Germany)
Christian Otte, Berlin (Germany)
Ion-George Anghelescu, Berlin (Germany)
Michael Bauer, Dresden (Germany)
Peter Falkai, München (Germany)
Andreas Meyer-Lindenberg, Mannheim (Germany)
Viktor Benjamin Nöhles, Berlin (Germany)
Andreas Reif, Frankfurt am Main (Germany)
Dan Rujescu, Wien (Austria)
Felix Bermpohl, Berlin (Germany)
Background: Major Depressive Disorder (MDD) is one of the most common mental illnesses worldwide and is strongly associated with suicidality. Commonly used treatments for MDD with suicidality include crisis intervention, oral antidepressants (although risk of suicidal behavior is high among non-responders and during the first 10-14 days of the treatment), benzodiazepines and lithium. Although several interventions addressing suicidality exist, only few studies have characterized in detail patients with MDD and suicidality, including treatment, clinical course and outcomes. OASIS-D is an investigator-initiated trial funded by Janssen Cilag GmbH.
Methods: Description of the design of the OASIS-D study of adults with MDD and suicidality aiming to identify standard of care and outcomes in a population targeted by novel treatment options.
Description: OASIS-D will take place between 11/2020 and 12/2022 at 8 German psychiatric University centers, collecting data on the standard of care of hospitalized patients aged 18-75 years with (i) MDD (population 1, aim 1), (ii) diagnosis of moderate/severe depressive episode and suicidality (population 2 derived from population 1, aim 2), and (iii) research interview-validated moderate or severe unipolar depressive episode and suicidality at ≥48 hours post admission, evaluated at baseline, inpatient discharge, and month 3 and 6 post-baseline (population 3 derived from population 2, aim 3).
Data will be collected for the following primary endpoints:
(i) characteristics (population 1);
(ii) concordance between clinical and research diagnosis its plus correlates (population 2);
(iii) duration and frequency of recurrence of suicidal symptoms and its correlates (population 3).
A variety of additional secondary and exploratory outcomes will also be assessed.
Conclusions: OASIS-D will contribute data to an understudied population of patients with MDD and suicidality.