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

Recruiting at 28 trial locations

Overseen By SLS-002 Study Team

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Seelos Therapeutics, Inc.

Must be taking: Antidepressants

Disqualifiers: Seizures, Bipolar, Schizophrenia, Substance use, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 2 weeks

236 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but it mentions that participants must be willing to take prescribed non-investigational antidepressant therapy during the study. There may be requirements for certain medications, so it's best to discuss your current medications with the study team.

What is the purpose of this trial?

This trial is testing a nasal spray with ketamine for people with severe depression who are at high risk of suicide. The spray aims to quickly improve mood by balancing brain chemicals. Esketamine was approved to treat treatment-resistant depression.

Eligibility Criteria

Inclusion Criteria

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SLS-002 (intranasal racemic ketamine) or placebo two times per week for 2 weeks with standard of care treatment

2 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

• SLS-002

Participant Groups

Group I: SLS-002 + Standard of care Experimental Treatment 3 Interventions

Participants will receive SLS-002 (intranasal racemic ketamine) 90 milligram (mg) two times per week for 2 weeks with standard of care treatment

Group II: Placebo + Standard of care Placebo Group 3 Interventions

Participants will receive intranasal placebo two times per week for 2 weeks with standard of care treatment

Who Is Running the Clinical Trial?

Seelos Therapeutics, Inc.

Lead Sponsor

Trials

6

Recruited

430+