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

Primary Purpose

Depressive Disorder, Major, Suicidal

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SLS-002
Placebo
Standard of care
Intranasal device
Sponsored by
Seelos Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder, Major focused on measuring Depression, Depressive disorder, SLS-002, Mental disorders, Suicide, Suicidal Ideation, Mood disorders, Behavioral symptoms, Self-injurious behavior, Ketamine, Antidepressive agents, Psychotropic drugs

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Seelos Investigational Site
  • Seelos Investigational Site
  • Seelos Investigational Site
  • Seelos Investigational Site
  • Seelos Investigational Site
  • Seelos Investigational Site
  • Seelos Investigational Site
  • Seelos Investigational Site
  • Seelos Investigational Site
  • Seelos Investigational Site
  • Seelos Investigational Site
  • Seelos Investigational Site
  • Seelos Investigational Site
  • Seelos Investigational Site
  • Seelos Investigational Site
  • Seelos Investigational Site
  • Seelos Investigational Site
  • Seelos Investigational Site
  • Seelos Investigational Site
  • Seelos Investigational Site
  • Seelos Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SLS-002 + Standard of care

Placebo + Standard of care

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Day 16
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.
Change From Baseline in Clinical Global Impression of Severity for Suicidal Ideation and Behavior (CGIS-SI/B) Scale at 24 Hours Post First Dose
Clinical global impression of severity for suicidal ideation and behavior (CGIS-SI/B) scale is revised version of the clinical global impression severity scale (CGI-S), a global rating scale that gives an overall measure of the severity of a participant's illness. The CGIS-SI/B summarizes the clinician's overall impression of severity of suicidal ideation and behavior on a 5-point scale from 1 (not at all suicidal) to 5 (among the most extremely suicidal), based on the totality of information available to the clinician.
Change From Baseline in Patient Global Impression of Severity for Suicidal Ideation and Behavior (PGIS-SI/B) Scale at 24 Hours Post First Dose
Patient global impression of severity for suicidal ideation and behavior (PGIS-SI/B) scale is revised version of the patient global impression severity scale (PGI-S), a global rating scale that gives the patient's perspective on their overall severity of suicidal impulses, thoughts, and behaviors. The PGIS-SI/B summarizes the patient's overall impression of severity of suicidal ideation and behavior on a 5-point scale from 1 (not present) to 5 (extremely severe).
Change From Baseline in Clinical Global Impression of Severity for Suicidal Ideation and Behavior (CGIS-SI/B) Scale at Day 16
Clinical global impression of severity for suicidal ideation and behavior (CGIS-SI/B) scale is revised version of the clinical global impression severity scale (CGI-S), a global rating scale that gives an overall measure of the severity of a participant's illness. The CGIS-SI/B summarizes the clinician's overall impression of severity of suicidal ideation and behavior on a 5-point scale from 1 (not at all suicidal) to 5 (among the most extremely suicidal), based on the totality of information available to the clinician.
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)
The Sheehan-Suicidality Tracking Scale Clinically Meaningful Change Measure (S-STS CMCM) is a clinician-rated outcome measure which assesses suicidal ideation and behavior on a standard 22-item scale, as well as multiple patient and clinician-rated items. The first 16 items are rated on a Likert-type scale ranging from 0 = not at all to 4 = extremely, where select scoring (i.e., 4 specific items are scored based on the highest score on 2 of those items) yields a total score ranging from 0 to 52.
Change From Baseline in Patient Global Impression of Severity for Suicidal Ideation and Behavior (PGIS-SI/B) Scale at Day 16
Patient global impression of severity for suicidal ideation and behavior (PGIS-SI/B) scale is revised version of the patient global impression severity scale (PGI-S), a global rating scale that gives the patient's perspective on their overall severity of suicidal impulses, thoughts, and behaviors. The PGIS-SI/B summarizes the patient's overall impression of severity of suicidal ideation and behavior on a 5-point scale from 1 (not present) to 5 (extremely severe).
Change from Baseline in Sheehan-Suicidality Tracking Scale Clinically Meaningful Change Measure (S-STS CMCM) Total Score at Day 16
The Sheehan-Suicidality Tracking Scale Clinically Meaningful Change Measure (S-STS CMCM) is a clinician-rated outcome measure which assesses suicidal ideation and behavior on a standard 22-item scale, as well as multiple patient and clinician-rated items. The first 16 items are rated on a Likert-type scale ranging from 0 = not at all to 4 = extremely.

Full Information

First Posted
December 9, 2020
Last Updated
September 25, 2023
Sponsor
Seelos Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04669665
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
December 17, 2020 (Actual)
Primary Completion Date
June 17, 2023 (Actual)
Study Completion Date
July 14, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seelos Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

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/

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Part 1 is open-label. Part 2 is a double-blind placebo-controlled study.
Allocation
Randomized
Enrollment
164 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SLS-002 + Standard of care
Arm Type
Experimental
Arm Description
Participants will receive SLS-002 (intranasal racemic ketamine) 90 milligram (mg) two times per week for 2 weeks with standard of care treatment
Arm Title
Placebo + Standard of care
Arm Type
Placebo Comparator
Arm Description
Participants will receive intranasal placebo two times per week for 2 weeks with standard of care treatment
Intervention Type
Drug
Intervention Name(s)
SLS-002
Other Intervention Name(s)
Ketamine hydrochloride
Intervention Description
Intranasal racemic ketamine hydrochloride 90 milligrams (mg)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Intranasal placebo
Intervention Type
Other
Intervention Name(s)
Standard of care
Intervention Description
Standard of care treatment will be determined by the treating physician(s) based on clinical judgement and practice guidelines
Intervention Type
Device
Intervention Name(s)
Intranasal device
Intervention Description
Device to deliver intranasal solution
Primary Outcome Measure Information:
Title
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at 24 Hours Post First Dose
Description
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.
Time Frame
Baseline (Day 1, predose) and 24 hours post first dose (Day 2)
Secondary Outcome Measure Information:
Title
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Day 16
Description
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.
Time Frame
Baseline (Day 1, predose) and 2 weeks post first dose (Day 16)
Title
Change From Baseline in Clinical Global Impression of Severity for Suicidal Ideation and Behavior (CGIS-SI/B) Scale at 24 Hours Post First Dose
Description
Clinical global impression of severity for suicidal ideation and behavior (CGIS-SI/B) scale is revised version of the clinical global impression severity scale (CGI-S), a global rating scale that gives an overall measure of the severity of a participant's illness. The CGIS-SI/B summarizes the clinician's overall impression of severity of suicidal ideation and behavior on a 5-point scale from 1 (not at all suicidal) to 5 (among the most extremely suicidal), based on the totality of information available to the clinician.
Time Frame
Baseline (Day 1, predose) and 24 hours post first dose (Day 2)
Title
Change From Baseline in Patient Global Impression of Severity for Suicidal Ideation and Behavior (PGIS-SI/B) Scale at 24 Hours Post First Dose
Description
Patient global impression of severity for suicidal ideation and behavior (PGIS-SI/B) scale is revised version of the patient global impression severity scale (PGI-S), a global rating scale that gives the patient's perspective on their overall severity of suicidal impulses, thoughts, and behaviors. The PGIS-SI/B summarizes the patient's overall impression of severity of suicidal ideation and behavior on a 5-point scale from 1 (not present) to 5 (extremely severe).
Time Frame
Baseline (Day 1, predose) and 24 hours post first dose (Day 2)
Title
Change From Baseline in Clinical Global Impression of Severity for Suicidal Ideation and Behavior (CGIS-SI/B) Scale at Day 16
Description
Clinical global impression of severity for suicidal ideation and behavior (CGIS-SI/B) scale is revised version of the clinical global impression severity scale (CGI-S), a global rating scale that gives an overall measure of the severity of a participant's illness. The CGIS-SI/B summarizes the clinician's overall impression of severity of suicidal ideation and behavior on a 5-point scale from 1 (not at all suicidal) to 5 (among the most extremely suicidal), based on the totality of information available to the clinician.
Time Frame
Baseline (Day 1, predose) and 2 weeks post first dose (Day 16)
Title
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)
Description
The Sheehan-Suicidality Tracking Scale Clinically Meaningful Change Measure (S-STS CMCM) is a clinician-rated outcome measure which assesses suicidal ideation and behavior on a standard 22-item scale, as well as multiple patient and clinician-rated items. The first 16 items are rated on a Likert-type scale ranging from 0 = not at all to 4 = extremely, where select scoring (i.e., 4 specific items are scored based on the highest score on 2 of those items) yields a total score ranging from 0 to 52.
Time Frame
Baseline (Day 1, predose) and 24 hours post first dose (Day 2)
Title
Change From Baseline in Patient Global Impression of Severity for Suicidal Ideation and Behavior (PGIS-SI/B) Scale at Day 16
Description
Patient global impression of severity for suicidal ideation and behavior (PGIS-SI/B) scale is revised version of the patient global impression severity scale (PGI-S), a global rating scale that gives the patient's perspective on their overall severity of suicidal impulses, thoughts, and behaviors. The PGIS-SI/B summarizes the patient's overall impression of severity of suicidal ideation and behavior on a 5-point scale from 1 (not present) to 5 (extremely severe).
Time Frame
Baseline (Day 1, predose) and 2 weeks post first dose (Day 16)
Title
Change from Baseline in Sheehan-Suicidality Tracking Scale Clinically Meaningful Change Measure (S-STS CMCM) Total Score at Day 16
Description
The Sheehan-Suicidality Tracking Scale Clinically Meaningful Change Measure (S-STS CMCM) is a clinician-rated outcome measure which assesses suicidal ideation and behavior on a standard 22-item scale, as well as multiple patient and clinician-rated items. The first 16 items are rated on a Likert-type scale ranging from 0 = not at all to 4 = extremely.
Time Frame
Baseline (Day 1, predose) and 2 weeks post first dose (Day 16)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Seelos Investigational Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Seelos Investigational Site
City
Panorama City
State/Province
California
ZIP/Postal Code
91402
Country
United States
Facility Name
Seelos Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Seelos Investigational Site
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Seelos Investigational Site
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Seelos Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Seelos Investigational Site
City
Miramar
State/Province
Florida
ZIP/Postal Code
33025
Country
United States
Facility Name
Seelos Investigational Site
City
Oakland Park
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Seelos Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
Seelos Investigational Site
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Seelos Investigational Site
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62781
Country
United States
Facility Name
Seelos Investigational Site
City
Gaithersburg
State/Province
Maryland
ZIP/Postal Code
20877
Country
United States
Facility Name
Seelos Investigational Site
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
Seelos Investigational Site
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Seelos Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Seelos Investigational Site
City
North Canton
State/Province
Ohio
ZIP/Postal Code
44720
Country
United States
Facility Name
Seelos Investigational Site
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Facility Name
Seelos Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Seelos Investigational Site
City
Richardson
State/Province
Texas
ZIP/Postal Code
75080
Country
United States
Facility Name
Seelos Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Facility Name
Seelos Investigational Site
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26505
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.

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

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