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

NCT04669665 | Completed Phase 2 FDA Drug FDA Device

• 1 other identifier: SLS-002-201
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 21

Brief 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.

Conditions

Depressive Disorder, Major; Suicidal

Keywords

Depression; Depressive disorder; SLS-002; Mental disorders; Suicide; Suicidal Ideation; Mood disorders; Behavioral symptoms; Self-injurious behavior; Ketamine; Antidepressive agents; Psychotropic drugs

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at 24 Hours Post First Dose

  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 possible score of 0 to 60.

  Baseline (Day 1, predose) and 24 hours post first dose (Day 2)

Secondary Outcomes (7)

• Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Day 16

  Baseline (Day 1, predose) and 2 weeks post first dose (Day 16)

• Change From Baseline in Clinical Global Impression of Severity for Suicidal Ideation and Behavior (CGIS-SI/B) Scale at 24 Hours Post First Dose

  Baseline (Day 1, predose) and 24 hours post first dose (Day 2)

• Change From Baseline in Patient Global Impression of Severity for Suicidal Ideation and Behavior (PGIS-SI/B) Scale at 24 Hours Post First Dose

  Baseline (Day 1, predose) and 24 hours post first dose (Day 2)

• Change From Baseline in Clinical Global Impression of Severity for Suicidal Ideation and Behavior (CGIS-SI/B) Scale at Day 16

  Baseline (Day 1, predose) and 2 weeks post first dose (Day 16)

• Change from Baseline in Sheehan-Suicidality Tracking Scale Clinically Meaningful Change Measure (S-STS CMCM) Total Score at 24 hours post first dose (Day 2)

  Baseline (Day 1, predose) and 24 hours post first dose (Day 2)

Study Arms (2)

SLS-002 + Standard of care

EXPERIMENTAL

Participants will receive SLS-002 (intranasal racemic ketamine) 90 milligram (mg) two times per week for 2 weeks with standard of care treatment

Drug: SLS-002; Other: Standard of care; Device: Intranasal device

Placebo + Standard of care

PLACEBO COMPARATOR

Participants will receive intranasal placebo two times per week for 2 weeks with standard of care treatment

Drug: Placebo; Other: Standard of care; Device: Intranasal device

Interventions

SLS-002 DRUG

Intranasal racemic ketamine hydrochloride 90 milligrams (mg)

Also known as: Ketamine hydrochloride

SLS-002 + Standard of care

Placebo DRUG

Intranasal placebo

Placebo + Standard of care

Standard of care OTHER

Standard of care treatment will be determined by the treating physician(s) based on clinical judgement and practice guidelines

Placebo + Standard of care; SLS-002 + Standard of care

Intranasal device DEVICE

Device to deliver intranasal solution

Placebo + Standard of care; SLS-002 + Standard of care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant with diagnosis of current MDD (unipolar without psychotic features) per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), with symptoms present for at least 4 weeks, based on psychiatric intake and confirmed by the Mini International Psychiatric Interview Version 7.02 for Suicidality Disorders (MINI).
• Participant has a Montgomery Åsberg Depression Rating Scale (MADRS) total score of ≥28 predose on Day 1, and has a score of 5 or 6 on item 10.
• 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.
• Participant is willing and able to take prescribed non-investigational antidepressant therapy(ies) at investigator's discretion for at least the duration of the study.

You may not qualify if:

• Participant has seizures, intellectual disability, a neurocognitive disorder or a lifetime diagnosis of bipolar disorder, any mood disorder with psychotic features, schizophrenia or other psychotic disorder, obsessive compulsive disorder, or antisocial personality disorder.
• In the investigator's opinion, participant has chronic, refractory treatment-resistant depression from \>4 adequate therapeutic trials of antidepressants (with or without adjuvants and/or ECT) as confirmed by Antidepressant Treatment Response Questionnaire (ATRQ).
• Participant has a body mass index (BMI) \>40 or \<18 at screening, uncontrolled hypertension, or any clinically significant medical condition that might confound the results.
• Participant meets the DSM-5 criteria for moderate or severe substance use disorder or a positive urine test for drugs of abuse.
• Participant does not meet or is not willing to comply with the requirements listed in prohibited and restricted medications and therapies in the protocol, as well as required washout periods prior to participation.

Sponsors & Collaborators

• Seelos Therapeutics, Inc.: lead

Study Sites (21)

Seelos Investigational Site

Orange, California, 92868, United States

Location

Seelos Investigational Site

Panorama City, California, 91402, United States

Location

Seelos Investigational Site

San Diego, California, 92103, United States

Location

Seelos Investigational Site

Hollywood, Florida, 33021, United States

Location

Seelos Investigational Site

Miami, Florida, 33144, United States

Location

Seelos Investigational Site

Miami Lakes, Florida, 33016, United States

Location

Seelos Investigational Site

Miramar, Florida, 33025, United States

Location

Seelos Investigational Site

Oakland Park, Florida, 33324, United States

Location

Seelos Investigational Site

Atlanta, Georgia, 30331, United States

Location

Seelos Investigational Site

Decatur, Georgia, 30030, United States

Location

Seelos Investigational Site

Springfield, Illinois, 62781, United States

Location

Seelos Investigational Site

Gaithersburg, Maryland, 20877, United States

Location

Seelos Investigational Site

Flowood, Mississippi, 39232, United States

Location

Seelos Investigational Site

Buffalo, New York, 14215, United States

Location

Seelos Investigational Site

Cincinnati, Ohio, 45219, United States

Location

Seelos Investigational Site

North Canton, Ohio, 44720, United States

Location

Seelos Investigational Site

DeSoto, Texas, 75115, United States

Location

Seelos Investigational Site

Houston, Texas, 77054, United States

Location

Seelos Investigational Site

Richardson, Texas, 75080, United States

Location

Seelos Investigational Site

Salt Lake City, Utah, 84108, United States

Location

Seelos Investigational Site

Morgantown, West Virginia, 26505, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression; Depressive Disorder; Mental Disorders; Suicide; Suicidal Ideation; Mood Disorders; Behavioral Symptoms; Self-Injurious Behavior

Interventions

Ketamine; Standard of Care

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Part 1 is open-label. Part 2 is a double-blind placebo-controlled study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part 1 is a single group. Part 2 is a parallel group 1:1 randomization of SLS-002 to placebo, plus standard of care.

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 17, 2020
• Study Start: December 17, 2020
• Primary Completion: June 17, 2023
• Study Completion: July 14, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share

Locations

US (21)