Safety of BI 1358894 in patients with major depressive disorder: Results and learnings from a phase II randomized decentralized clinical trial.

Christopher Reist¹, Peide Li², Thuy Le Nguyen², Sigurd D Süssmuth³

¹Science 37, Culver City, CA, USA.

²Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.

³Boehringer Ingelheim International GmbH, Biberach an der Riss, Germany.

PubMed PMC DOI PDF

Abstract

The feasibility of conducting a fully remote, interventional, phase II decentralized clinical trial (DCT) was investigated in major depressive disorder (MDD). Key learnings were collated to improve future DCTs. A double-blind, placebo-controlled, parallel-group, DCT enrolled adult MDD patients with inadequate response to first-line antidepressant monotherapy (ongoing ≥8 weeks) and a Montgomery-Åsb…

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