NCT04669665

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

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: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 164 (actual)
• Sponsor: Seelos Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a 2-part study: Part 1 is open-label, while Part 2 is a randomized, double-blind, placebo-controlled, multicenter study. The study will enroll participants with MDD for whom a physician has assessed to be at risk for suicide. The study will consist of a screening evaluation, a treatment period, and a safety follow-up period. Participants' safety will be evaluated throughout the study. If you or a loved one are having thoughts of suicide, please seek immediate medical help. Go to the emergency room or call the National Suicide Prevention Lifeline at 1-800-273-8255. Potential participants may visit http://frontiersstudy.com/

Conditions

• Depressive Disorder, Major
• Suicidal

Interventions

Type	Name	Description
DRUG	SLS-002	Intranasal racemic ketamine hydrochloride 90 milligrams (mg)
DRUG	Placebo	Intranasal placebo
OTHER	Standard of care	Standard of care treatment will be determined by the treating physician(s) based on clinical judgement and practice guidelines
DEVICE	Intranasal device	Device to deliver intranasal solution

Timeline

• Start date: 2020-12-17
• Primary completion: 2023-06-17
• Completion: 2023-07-14
• First posted: 2020-12-17
• Last updated: 2023-09-28

Locations

21 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study