drugset / Trial / NCT04669665

A Study of SLS-002 (Intranasal Racemic Ketamine) in Adults With Major Depressive Disorder at Imminent Risk of Suicide

NCT04669665

Phase 2 Completed 164 enrolled Seelos Therapeutics, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of the study is to evaluate the efficacy, safety, and tolerability of SLS-002 (intranasal racemic ketamine) in addition to standard of care on symptoms of Major Depressive Disorder (MDD) and suicidality, in participants who are assessed to be at imminent risk for suicide, as measured by the change from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) total score at 24 hours post first dose.

Timeline

Start
2020-12-17
Primary completion
2023-06-17
Completion
2023-07-14

Drugs

EvaluationDrugModalityDoseRoute
Subject SLS-002 Unknown 90 mg Intranasal