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NMDA Receptor Antagonist

SLS-002 for Depression

Phase 2
Waitlist Available
Led By Paul Kim, MD, PhD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The subject has a Clinical Global Impression (CGI) of Severity for Suicidal Ideation and Behavior (SI/B) (CGIS-SI/B) score of ≥4 predose on Day 1.
In the investigator's opinion, the subject 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 (p12 top) predose on Day 1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 24 hours post first dose
Awards & highlights

Study Summary

This trial will test whether adding the drug ketamine to standard care can help relieve symptoms of depression and suicidality in adults with Major Depressive Disorder who are at imminent risk for suicide.

Eligible Conditions
  • Depression
  • Suicidal Ideation
  • Suicidal Thoughts

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have a score of 4 or higher on a test that measures how severe your suicidal thoughts and behavior are.
Select...
The investigator thinks you need to be hospitalized for your own safety due to a high risk of suicide. You also scored high on a suicide risk assessment test.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 24 hours post first dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 24 hours post first dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at 24 Hours Following Initial Dose
Secondary outcome measures
Change From Baseline in Clinical Global Impression of Severity for Suicidal Ideation and Behavior (CGIS-SI/B) Scale at 24 Hours Following Initial Dose
Change From Baseline in Clinical Global Impression of Severity for Suicidal Ideation and Behavior (CGIS-SI/B) Scale at Day 16
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Day 16
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: 90mg SLS-002 plus Standard of careExperimental Treatment2 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 carePlacebo Group2 Interventions
Participants will receive intranasal placebo two times per week for 16 days plus standard of care treatment for a total of 5 doses.

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,246 Previous Clinical Trials
14,816,760 Total Patients Enrolled
56 Trials studying Depression
29,565 Patients Enrolled for Depression
Seelos Therapeutics, Inc.Industry Sponsor
5 Previous Clinical Trials
642 Total Patients Enrolled
1 Trials studying Depression
236 Patients Enrolled for Depression
Paul Kim, MD, PhDPrincipal InvestigatorJohns Hopkins Hospital Department of Psychiatry and Behavioral Sciences
1 Previous Clinical Trials

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial include adults who are of legal age?

"This particular medical trial has a participant age limit of 18 to 65 years old. On the other hand, there are 244 clinical trials for minors and 1071 studies open to seniors in this demographic range."

Answered by AI

Am I eligible to join this experimental research?

"This clinical trial seeks 10 individuals aged 18 to 65 who suffer from depression, and meet certain criteria. To be selected for the study, patients must demonstrate a capacity to comprehend English or their local language, have been diagnosed with MDD (unipolar without psychotic features), score at least 28 on MADRS scale pre-dosing on Day 1., 5 or 6 on item 10 of MADRS predose on Day 1., 4+ CGIS-SI/B score pre-dose day one; if deemed by investigator as necessitating inpatient care due to high suicide risk then 15+ S-STS CMCM total score with 6"

Answered by AI

Are there any health risks associated with ingesting SLS-002?

"There is some limited evidence of SLS-002's safety, thus it was awarded a score of 2. Unfortunately, there remains insufficient data to confirm its efficacy at this time."

Answered by AI

Is the enrollment period still open for this clinical trial?

"As of now, this research is not recruiting participants. This trial was initiated on August 15th 2022 and last modified June 9th 2022. Nevertheless, there are 1449 other trials currently accepting enrolment applications."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Johns Hopkins Hospital
What portion of applicants met pre-screening criteria?
Met criteria
~4 spots leftby Apr 2025