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

Overseen by Paul Kim, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Johns Hopkins University

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a nasal spray with ketamine to help adults with severe depression who are at risk of suicide. The spray works by quickly changing brain activity to improve mood and reduce suicidal thoughts. Esketamine, a form of ketamine, was approved to treat difficult-to-treat depression.

Research Team

Paul Kim, MD, PhD

Principal Investigator

Johns Hopkins Hospital Department of Psychiatry and Behavioral Sciences

Eligibility Criteria

Inclusion Criteria

The person has thoughts of wanting to harm themselves and has expressed these thoughts during screening and baseline assessments.

Subject able to speak, read, and understand English and/or the language of the investigative staff

Subject is 18 to 65 years of age at the time of informed consent

Exclusion Criteria

Subject has known, uncontrolled hypertension or blood pressure that should exclude the subject at screening or baseline

Subject has positive hepatitis B, hepatitis C, or HIV results at screening

Subject was previously enrolled in the current study

Treatment Details

Interventions

• SLS-002 (NMDA Receptor Antagonist)

Participant Groups

Group I: 90mg SLS-002 plus Standard of care Experimental Treatment 2 Interventions

Participants will receive 90mg SLS-002 (intranasal racemic ketamine) two times per week for 16 days including standard of care treatment. Total of 5 doses of SLS-002.

Group II: Placebo plus Standard of care Placebo Group 2 Interventions

Participants will receive intranasal placebo two times per week for 16 days plus standard of care treatment for a total of 5 doses.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Theodore DeWeese

Johns Hopkins University

Chief Executive Officer since 2023

MD from an unspecified institution

Allen Kachalia

Johns Hopkins University

Chief Medical Officer since 2023

MD from an unspecified institution

Seelos Therapeutics, Inc.

Industry Sponsor

Trials

6

Recruited

430+