Intranasal Ketamine for Major Depressive Disorder

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called SLS-002, an intranasal form of racemic ketamine, to determine its effectiveness in reducing symptoms of Major Depressive Disorder (MDD) and suicidality in individuals at immediate risk of suicide. Participants will receive either the active treatment or a placebo, alongside their usual care, to assess whether SLS-002 provides additional benefits. Suitable candidates for this trial should have experienced MDD symptoms for at least four weeks and be at high risk for suicide, necessitating psychiatric hospitalization. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that SLS-002 is likely to be safe for humans?

Research shows that intranasal racemic ketamine, such as SLS-002, is generally safe for individuals with treatment-resistant depression (TRD). Studies have found it to have good safety results and strong antidepressant effects. A similar treatment has proven safe and effective for both short-term and long-term use.

While specific information on side effects for SLS-002 is not yet available, evidence from similar treatments suggests it is likely well-tolerated. This study is in phase 2, indicating that the treatment has already passed initial safety tests in humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for MDD?

Unlike standard treatments for major depressive disorder, which typically involve oral antidepressants or talk therapy, SLS-002 is administered intranasally and leverages the active ingredient racemic ketamine. This treatment is designed to work faster than conventional antidepressants, which often take weeks to become effective. Researchers are particularly excited because SLS-002 targets NMDA receptors in the brain, potentially providing rapid relief for individuals at imminent risk of suicide, a benefit that current options struggle to offer.

What evidence suggests that SLS-002 might be an effective treatment for Major Depressive Disorder and suicidality?

Studies have shown that intranasal racemic ketamine can help people with treatment-resistant depression (TRD). Previous research indicates it is generally well-tolerated and effectively reduces depression. Evidence suggests this type of ketamine might outperform similar treatments, like esketamine. Nearly half of the patients with major depressive disorder (MDD) who tried a related treatment improved within a few weeks. In this trial, participants will receive either SLS-002, an intranasal racemic ketamine, or a placebo, both alongside standard care treatment. These findings suggest that SLS-002 could be promising for reducing symptoms of depression and suicidal thoughts. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• SLS-002

How Is the Trial Designed?

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+

Citations

1.

sciencedirect.com

sciencedirect.com/science/article/pii/S2666915325000848

Intranasal racemic ketamine in treatment-resistant ...

Intranasal racemic ketamine is an effective, well-tolerated treatment for TRD, with favorable safety outcomes and substantial antidepressant effects.

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40930174/

Real-world clinical data on the long-term effectiveness and ...

The commercially developed intranasal spray containing S-ketamine has demonstrated short and long-term efficacy and safety in phase 3 clinical trials leading to ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04669665

NCT04669665 | A Study of SLS-002 (Intranasal Racemic ...

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 ...

4.

bmcpsychiatry.biomedcentral.com

bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-024-06448-x

Intranasal racemic ketamine maintenance therapy for patients ...

Although IN esketamine has long-term safety and efficacy data, there are concerns esketamine may be less effective than racemic ketamine [4].

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10747365/

The Efficacy and Safety of Intranasal Formulations ...

2022 observed that 48% of MDD patients with TRD responded 18 days after the first IN esketamine treatment, and 37% achieved remission after 21 ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38449472/

A Phase 2 Open Label Study of Efficacy, Safety, and ...

SLS-002 was developed as an investigational intranasal racemic ketamine for the treatment of SI/B in individuals with MDD.

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0165032725016349

Real-world clinical data on the long-term effectiveness and ...

The aim of this study was to report the effectiveness and safety of ongoing racemic ketamine treatment for TRD for up to six months in real- ...