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

NCT04669665 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2023-09-28

No results posted yet for this study

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.

Conditions

  • Depressive Disorder, Major
  • Suicidal

Interventions

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

Sponsors & Collaborators

  • Seelos Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-17
Primary Completion
2023-06-17
Completion
2023-07-14
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04669665 on ClinicalTrials.gov