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 helpNCT Number NCT04669665
Sponsors & Collaborators
Seelos TherapeuticsSeelos 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 ScaleA ten-item diagnostic questionnaire used to measure the severity of depressive symptoms in patients with mood disorders.