A Study of SLS-002 (Intranasal Racemic Ketamine) in Adults With Major Depressive Disorder at Imminent Risk of Suicide
Public ClinicalTrials.gov record NCT04669665. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A 2-part Phase 2 Study to Assess the Efficacy, Safety, and Tolerability of SLS-002 (Intranasal Racemic Ketamine) Administered to Adults With Major Depressive Disorder at Imminent Risk of Suicide
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04669665
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 164 participants
Conditions and interventions
Conditions
Interventions
- SLS-002 Drug
- Placebo Drug
- Standard of care Other
- Intranasal device Device
Drug · Other · Device
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 17, 2020 (Actual)
- Primary completion
- Jun 17, 2023 (Actual)
- Completion
- Jul 14, 2023 (Actual)
- Last update posted
- Sep 28, 2023
2020 – 2023
United States locations
- U.S. sites
- 21
- U.S. states
- 11
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Seelos Investigational Site | Orange | California | 92868 | — |
| Seelos Investigational Site | Panorama City | California | 91402 | — |
| Seelos Investigational Site | San Diego | California | 92103 | — |
| Seelos Investigational Site | Hollywood | Florida | 33021 | — |
| Seelos Investigational Site | Miami | Florida | 33144 | — |
| Seelos Investigational Site | Miami Lakes | Florida | 33016 | — |
| Seelos Investigational Site | Miramar | Florida | 33025 | — |
| Seelos Investigational Site | Oakland Park | Florida | 33324 | — |
| Seelos Investigational Site | Atlanta | Georgia | 30331 | — |
| Seelos Investigational Site | Decatur | Georgia | 30030 | — |
| Seelos Investigational Site | Springfield | Illinois | 62781 | — |
| Seelos Investigational Site | Gaithersburg | Maryland | 20877 | — |
| Seelos Investigational Site | Flowood | Mississippi | 39232 | — |
| Seelos Investigational Site | Buffalo | New York | 14215 | — |
| Seelos Investigational Site | Cincinnati | Ohio | 45219 | — |
| Seelos Investigational Site | North Canton | Ohio | 44720 | — |
| Seelos Investigational Site | DeSoto | Texas | 75115 | — |
| Seelos Investigational Site | Houston | Texas | 77054 | — |
| Seelos Investigational Site | Richardson | Texas | 75080 | — |
| Seelos Investigational Site | Salt Lake City | Utah | 84108 | — |
| Seelos Investigational Site | Morgantown | West Virginia | 26505 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04669665, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 28, 2023 · Synced Nov 3, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04669665 live on ClinicalTrials.gov.