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CompletedPhase 2

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

NCT04669665 · Seelos Therapeutics, Inc.

Closed to entry
Status
Not accepting participants
Phase 2
Phase
164
Target enrolment
21
Study sites
11 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at 24 Hours Post First Dose

    Measured over Baseline (Day 1, predose) and 24 hours post first dose (Day 2)

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 65 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * Participant with diagnosis of current MDD (unipolar without psychotic features) per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), with symptoms present for at least 4 weeks, based on psychiatric intake and confirmed by the Mini International Psychiatric Interview Version 7.02 for Suicidality Disorders (MINI). * Participant has a Montgomery Åsberg Depression Rating Scale (MADRS) total score of ≥28 predose on Day 1, and has a score of 5 or 6 on item 10. * Participant has a Clinical Global Impression of Severity for Suicidal Ideation and Behavior (CGIS-SI/B) score of ≥4 predose on Day 1. * Participant requires psychiatric hospitalization due to significant risk of suicide, has ≥15 on the S-STS CMCM total score, and a score of 6-9 (inclusive) on the S-STS CMCM Clinician judgment of subject's risk of a suicide attempt or death by suicide at this time. * Participant has a history of previous suicide attempt(s), as confirmed on the Columbia Suicide Severity Rating Scale (C-SSRS) with a history of at least one actual attempt, or if the attempt was interrupted or aborted, is judged to have been serious in intent. * Participant is willing and able to take prescribed non-investigational antidepressant therapy(ies) at investigator's discretion for at least the duration of the study. Exclusion Criteria: * Participant has seizures, intellectual disability, a neurocognitive disorder or a lifetime diagnosis of bipolar disorder, any mood disorder with psychotic features, schizophrenia or other psychotic disorder, obsessive compulsive disorder, or antisocial personality disorder. * In the investigator's opinion, participant has chronic, refractory treatment-resistant depression from \>4 adequate therapeutic trials of antidepressants (with or without adjuvants and/or ECT) as confirmed by Antidepressant Treatment Response Questionnaire (ATRQ). * Participant has a body mass index (BMI) \>40 or \<18 at screening, uncontrolled hypertension, or any clinically significant medical condition that might confound the results. * Participant meets the DSM-5 criteria for moderate or severe substance use disorder or a positive urine test for drugs of abuse. * Participant does not meet or is not willing to comply with the requirements listed in prohibited and restricted medications and therapies in the protocol, as well as required washout periods prior to participation.

Where

21 study sites

FacilityCityRegionCountry
Seelos Investigational SiteOrangeCaliforniaUnited States
Seelos Investigational SitePanorama CityCaliforniaUnited States
Seelos Investigational SiteSan DiegoCaliforniaUnited States
Seelos Investigational SiteHollywoodFloridaUnited States
Seelos Investigational SiteMiamiFloridaUnited States
Seelos Investigational SiteMiami LakesFloridaUnited States
Seelos Investigational SiteMiramarFloridaUnited States
Seelos Investigational SiteOakland ParkFloridaUnited States
Seelos Investigational SiteAtlantaGeorgiaUnited States
Seelos Investigational SiteDecaturGeorgiaUnited States
Seelos Investigational SiteSpringfieldIllinoisUnited States
Seelos Investigational SiteGaithersburgMarylandUnited States
Seelos Investigational SiteFlowoodMississippiUnited States
Seelos Investigational SiteBuffaloNew YorkUnited States
Seelos Investigational SiteCincinnatiOhioUnited States
Seelos Investigational SiteNorth CantonOhioUnited States
Seelos Investigational SiteDeSotoTexasUnited States
Seelos Investigational SiteHoustonTexasUnited States
Seelos Investigational SiteRichardsonTexasUnited States
Seelos Investigational SiteSalt Lake CityUtahUnited States
Seelos Investigational SiteMorgantownWest VirginiaUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT04669665 on ClinicalTrials.gov →

Last updated in the registry 2023-09-28. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits