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

Depression Clinical Trial

Official title: A 2-Part Phase 2 Study to Assess the Efficacy, Safety, and Tolerability of SLS-002 (Intranasal Racemic Ketamine) Administered to Adults With Major Depressive Disorder at Imminent Risk of Suicide

Status Not yet recruiting

Clinical Trial 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 depression and suicidality in adults with Major Depressive Disorder who are at imminent risk for suicide.

Clinical Trial Description

This Phase 2, multicenter, 2-part study in adult subjects diagnosed with MDD at imminent risk of suicide will evaluate the efficacy, safety, and tolerability of intranasally (IN) administered SLS-002 (IN spray) plus SOC. In Part 1, 16 subjects will receive open-label SLS-002 (90 mg). Part 2 of the study is double-blind and 220 subjects will be randomized 1:1 to receive either SLS-002 (90 mg) or matching placebo. The Johns Hopkins Hospital Department of Psychiatry and Behavioral Sciences will be working with Seelos Therapeutics on Part 2 of the study with an estimated enrollment of 10 participants.

After admission to the emergency room or hospital, each subject will participate in a 1- to 2-day screening phase, a 16-day treatment phase including standard of care during which study drug will be administered 2 times per week for a total of 5 doses, and a 2-week safety follow-up phase for a total of up to 5 weeks of study participation. Subjects will be treated as inpatients for approximately 7 days (including screening), and assuming the subject meets readiness for discharge criteria, will be discharged on Day 6 to continue the trial as outpatients, provided it is clinically appropriate to do so. ;

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Suicidal Behavior
• Suicidal Ideation
• Suicide

• NCT number: NCT05417074
• Study type: Interventional
• Source: Johns Hopkins University
• Contact: Paul Kim, MD, PhD
• Phone: 4105020622
• Email: pmkim@jhmi.edu
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: August 15, 2022
• Completion date: August 15, 2023