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

NCT ID: NCT04669665

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 164 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-17
• Study Completion Date: 2023-07-14

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.

Detailed Description

This is a 2-part study: Part 1 is open-label, while Part 2 is a randomized, double-blind, placebo-controlled, multicenter study. The study will enroll participants with MDD for whom a physician has assessed to be at risk for suicide. The study will consist of a screening evaluation, a treatment period, and a safety follow-up period. Participants' safety will be evaluated throughout the study. If you or a loved one are having thoughts of suicide, please seek immediate medical help. Go to the emergency room or call the National Suicide Prevention Lifeline at 1-800-273-8255.

Potential participants may visit http://frontiersstudy.com/

Conditions

Depressive Disorder, Major; Suicidal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SLS-002 + Standard of care

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

Group Type: EXPERIMENTAL

SLS-002

Intervention Type: DRUG

Intranasal racemic ketamine hydrochloride 90 milligrams (mg)

Standard of care

Intervention Type: OTHER

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

Intranasal device

Intervention Type: DEVICE

Device to deliver intranasal solution

Placebo + Standard of care

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Intranasal placebo

Standard of care

Intervention Type: OTHER

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

Intranasal device

Intervention Type: DEVICE

Device to deliver intranasal solution

Interventions

SLS-002

Intranasal racemic ketamine hydrochloride 90 milligrams (mg)

Intervention Type: DRUG

Placebo

Intranasal placebo

Intervention Type: DRUG

Standard of care

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

Intervention Type: OTHER

Intranasal device

Device to deliver intranasal solution

Intervention Type: DEVICE

Other Intervention Names

Ketamine hydrochloride

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seelos Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Seelos Investigational Site

Orange, California, United States

Seelos Investigational Site

Panorama City, California, United States

Seelos Investigational Site

San Diego, California, United States

Seelos Investigational Site

Hollywood, Florida, United States

Seelos Investigational Site

Miami, Florida, United States

Seelos Investigational Site

Miami Lakes, Florida, United States

Seelos Investigational Site

Miramar, Florida, United States

Seelos Investigational Site

Oakland Park, Florida, United States

Seelos Investigational Site

Atlanta, Georgia, United States

Seelos Investigational Site

Decatur, Georgia, United States

Seelos Investigational Site

Springfield, Illinois, United States

Seelos Investigational Site

Gaithersburg, Maryland, United States

Seelos Investigational Site

Flowood, Mississippi, United States

Seelos Investigational Site

Buffalo, New York, United States

Seelos Investigational Site

Cincinnati, Ohio, United States

Seelos Investigational Site

North Canton, Ohio, United States

Seelos Investigational Site

DeSoto, Texas, United States

Seelos Investigational Site

Houston, Texas, United States

Seelos Investigational Site

Richardson, Texas, United States

Seelos Investigational Site

Salt Lake City, Utah, United States

Seelos Investigational Site

Morgantown, West Virginia, United States

Countries

United States

Other Identifiers

SLS-002-201

Identifier Type: -

Identifier Source: org_study_id