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

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.

Topic Depression Suicidality
Compound Psilocybin Placebo
Country United States of America
Visit trial
Status Recruiting
Results Published
Start date 17 December 2020
End date 01 December 2022
Chance of happening 90%
Phase Phase II
Design Blinded
Type Interventional
Generation Second
Participants 136
Sex All
Age 18- 65
Therapy No

Trial Details

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

NCT Number NCT04669665

Sponsors & Collaborators

Seelos Therapeutics
Seelos Therapeutics is developing psychedelic compounds to deal with needs in CNS disorders and rare diseases. The company buys IP for which they do (pre-)clinical R&D to bring those compounds closer to market.

Measures Used

Montgomery-Asberg Depression Rating Scale
A ten-item diagnostic questionnaire used to measure the severity of depressive symptoms in patients with mood disorders.

Data attribution

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