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NCT04669665 · ClinicalTrials.gov registry record · Phase 2
A Study of SLS-002 (Intranasal Racemic Ketamine) in Adults With Major Depressive Disorder at Imminent Risk of Suicide
A Phase 2 study of Depressive Disorder, Major and Suicidal, sponsored by Seelos Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 164
- Enrollment target
- 20
- Study locations
NCT04669665: Completed Phase 2 study of Depressive Disorder, Major and Suicidal, sponsored by Seelos Therapeutics.
NCT04669665 is a Phase 2 study of Depressive Disorder, Major and Suicidal that has completed, run by Seelos Therapeutics. The registered enrollment target is 164 participants, below the 239-participant average among 52 other Depressive Disorder, Major trials with a reported enrollment target (31% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04669665, a Phase 2 study of Depressive Disorder, Major and Suicidal, has completed, sponsored by Seelos Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 164 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
MADRS is clinician-rated scale designed to be used in participants with Major Depressive Disorder (MDD) to measure depression severity and detect changes due to antidepressant treatment. It evaluates apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic and suicidal thoughts. Scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of symptoms), summed for total
Conditions Studied
Interventions
- DRUG Placebo
- OTHER Standard of care
- DRUG SLS-002
- DEVICE Intranasal device
Study Locations (20)
Florida
- Seelos Investigational Site - Hollywood
- Seelos Investigational Site - Miami
- Seelos Investigational Site - Miami Lakes
- Seelos Investigational Site - Miramar
- Seelos Investigational Site - Oakland Park
California
- Seelos Investigational Site - Orange
- Seelos Investigational Site - Panorama City
- Seelos Investigational Site - San Diego
Texas
- Seelos Investigational Site - DeSoto
- Seelos Investigational Site - Houston
- Seelos Investigational Site - Richardson
Georgia
- Seelos Investigational Site - Atlanta
- Seelos Investigational Site - Decatur
Ohio
- Seelos Investigational Site - Cincinnati
- Seelos Investigational Site - North Canton
Illinois
- Seelos Investigational Site - Springfield
Maryland
- Seelos Investigational Site - Gaithersburg
Mississippi
- Seelos Investigational Site - Flowood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 164 participants |
| Start Date | 2020-12-17 |
| Est. Completion | 2023-07-14 |
| Phase | Phase 2 |
What the finished NCT04669665 record still lists
NCT04669665 is an interventional study that assigns participants to a tested intervention. The registered 164 participants enrollment target is mid-sized for trials with a published cap, below the 239-participant average among 52 other Depressive Disorder, Major trials with a reported enrollment target (31% lower).
The record links to 2 conditions, with Depressive Disorder, Major appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT04669665 names 20 study sites across 10 states, led by Florida, California, Texas.
Frequently Asked Questions
What is clinical trial NCT04669665 about?
NCT04669665 is a clinical study titled "A Study of SLS-002 (Intranasal Racemic Ketamine) in Adults With Major Depressive Disorder at Imminent Risk of Suicide". 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 ...
What is the current status of trial NCT04669665?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 164 participants. The study started on 2020-12-17. Estimated completion is 2023-07-14.
What conditions does trial NCT04669665 study?
This clinical trial studies the following conditions: Depressive Disorder, Major, Suicidal.
What interventions are being tested in trial NCT04669665?
The interventions under investigation include: Placebo (DRUG), Standard of care (OTHER), SLS-002 (DRUG), Intranasal device (DEVICE).
Who is sponsoring clinical trial NCT04669665?
This trial is sponsored by Seelos Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04669665 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04669665's enrollment target sits among peer trials
164 25th of 52 higher than 28 of 52 other Depressive Disorder, Major trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depressive Disorder, Major trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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