Clinical trial NCT04669665: A Study of SLS-002 (Intranasal Racemic Ketamine) in Adults With Major Depressive Disorder at Imminent Risk of Suicide
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: Seelos Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2020-12-17
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Part 1 is a single group. Part 2 is a parallel group 1:1 randomization of SLS-002 to placebo, plus standard of care.
Primary purpose: TREATMENT

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/

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.

Primary outcomes:
measure: Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at 24 Hours Post First Dose
timeFrame: Baseline (Day 1, predose) and 24 hours post first dose (Day 2)
Secondary outcomes:
measure: Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Day 16
timeFrame: Baseline (Day 1, predose) and 2 weeks post first dose (Day 16)
measure: Change From Baseline in Clinical Global Impression of Severity for Suicidal Ideation and Behavior (CGIS-SI/B) Scale at 24 Hours Post First Dose
timeFrame: Baseline (Day 1, predose) and 24 hours post first dose (Day 2)
measure: Change From Baseline in Patient Global Impression of Severity for Suicidal Ideation and Behavior (PGIS-SI/B) Scale at 24 Hours Post First Dose
timeFrame: Baseline (Day 1, predose) and 24 hours post first dose (Day 2)
measure: Change From Baseline in Clinical Global Impression of Severity for Suicidal Ideation and Behavior (CGIS-SI/B) Scale at Day 16
timeFrame: Baseline (Day 1, predose) and 2 weeks post first dose (Day 16)
measure: 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)
timeFrame: Baseline (Day 1, predose) and 24 hours post first dose (Day 2)
measure: Change From Baseline in Patient Global Impression of Severity for Suicidal Ideation and Behavior (PGIS-SI/B) Scale at Day 16
timeFrame: Baseline (Day 1, predose) and 2 weeks post first dose (Day 16)
measure: Change from Baseline in Sheehan-Suicidality Tracking Scale Clinically Meaningful Change Measure (S-STS CMCM) Total Score at Day 16
timeFrame: Baseline (Day 1, predose) and 2 weeks post first dose (Day 16)
Other outcomes:
Locations:
city: Orange
country: United States
facility: Seelos Investigational Site
state: California
city: Panorama City
country: United States
facility: Seelos Investigational Site
state: California
city: San Diego
country: United States
facility: Seelos Investigational Site
state: California
city: Hollywood
country: United States
facility: Seelos Investigational Site
state: Florida
city: Miami Lakes
country: United States
facility: Seelos Investigational Site
state: Florida
city: Miami
country: United States
facility: Seelos Investigational Site
state: Florida
city: Miramar
country: United States
facility: Seelos Investigational Site
state: Florida
city: Oakland Park
country: United States
facility: Seelos Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Seelos Investigational Site
state: Georgia
city: Decatur
country: United States
facility: Seelos Investigational Site
state: Georgia
city: Springfield
country: United States
facility: Seelos Investigational Site
state: Illinois
city: Gaithersburg
country: United States
facility: Seelos Investigational Site
state: Maryland
city: Flowood
country: United States
facility: Seelos Investigational Site
state: Mississippi
city: Buffalo
country: United States
facility: Seelos Investigational Site
state: New York
city: Cincinnati
country: United States
facility: Seelos Investigational Site
state: Ohio
city: North Canton
country: United States
facility: Seelos Investigational Site
state: Ohio
city: DeSoto
country: United States
facility: Seelos Investigational Site
state: Texas
city: Houston
country: United States
facility: Seelos Investigational Site
state: Texas
city: Richardson
country: United States
facility: Seelos Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Seelos Investigational Site
state: Utah
city: Morgantown
country: United States
facility: Seelos Investigational Site
state: West Virginia
Study officials:
References: