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

Sponsor
Seelos Therapeutics, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04669665
Collaborator
(none)
236
30
2
23.5
7.9
0.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: SLS-002
  • Drug: Placebo
  • Other: Standard of care
  • Device: Intranasal device
Phase 2

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/

Study Design

Study Type:
Interventional
Anticipated Enrollment :
236 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Part 1 is open-label. Part 2 is a double-blind placebo-controlled study.
Primary Purpose:
Treatment
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
Actual Study Start Date :
Dec 17, 2020
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

Drug: SLS-002
Intranasal racemic ketamine hydrochloride 90 milligrams (mg)
Other Names:
  • Ketamine hydrochloride
  • Other: Standard of care
    Standard of care treatment will be determined by the treating physician(s) based on clinical judgement and practice guidelines

    Device: Intranasal device
    Device to deliver intranasal solution

    Placebo Comparator: Placebo + Standard of care

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

    Drug: Placebo
    Intranasal placebo

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

    Device: Intranasal device
    Device to deliver intranasal solution

    Outcome Measures

    Primary Outcome Measures

    1. Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at 24 Hours Post First Dose [Baseline (Day 1, predose) and 24 hours post first dose (Day 2)]

      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

    1. 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)]

      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.

    2. 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)]

      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.

    3. 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)]

      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).

    4. 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)]

      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.

    5. 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)]

      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.

    6. Change from Baseline in Sheehan-Suicidality Tracking Scale Clinically Meaningful Change Measure (S-STS CMCM) Total Score at Day 16 [Baseline (Day 1, predose) and 2 weeks post first dose (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.

    7. Change From Baseline in Patient Global Impression of Severity for Suicidal Ideation and Behavior (PGIS-SI/B) Scale at Day 16 [Baseline (Day 1, predose) and 2 weeks post first dose (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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seelos Investigational Site Tempe Arizona United States 85284
    2 Seelos Investigational Site Culver City California United States 90230
    3 Seelos Investigational Site Glendale California United States 91206
    4 Seelos Investigational Site Orange California United States 92868
    5 Seelos Investigational Site Panorama City California United States 91402
    6 Seelos Investigational Site San Diego California United States 92103
    7 Seelos Investigational Site Farmington Connecticut United States 06030
    8 Seelos Investigational Site Miami Lakes Florida United States 33016
    9 Seelos Investigational Site Miami Florida United States 33135
    10 Seelos Investigational Site Miami Florida United States 33144
    11 Seelos Investigational Site Miramar Florida United States 33025
    12 Seelos Investigational Site Oakland Park Florida United States 33324
    13 Seelos Investigational Site Atlanta Georgia United States 30331
    14 Seelos Investigational Site Atlanta Georgia United States 30338
    15 Seelos Investigational Site Decatur Georgia United States 30030
    16 Seelos Investigational Site Springfield Illinois United States 62781
    17 Seelos Investigational Site Alexandria Louisiana United States 71303
    18 Seelos Investigational Site Baltimore Maryland United States 21287
    19 Seelos Investigational Site Gaithersburg Maryland United States 20877
    20 Seelos Investigational Site Flowood Mississippi United States 39232
    21 Seelos Investigational Site Saint Louis Missouri United States 63128
    22 Seelos Investigational Site Buffalo New York United States 14215
    23 Seelos Investigational Site Cincinnati Ohio United States 45219
    24 Seelos Investigational Site North Canton Ohio United States 44720
    25 Seelos Investigational Site DeSoto Texas United States 75115
    26 Seelos Investigational Site Houston Texas United States 77054
    27 Seelos Investigational Site Richardson Texas United States 75080
    28 Seelos Investigational Site Richmond Texas United States 77407
    29 Seelos Investigational Site Springville Utah United States 84663
    30 Seelos Investigational Site Morgantown West Virginia United States 26505

    Sponsors and Collaborators

    • Seelos Therapeutics, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Seelos Therapeutics, Inc.
    ClinicalTrials.gov Identifier:
    NCT04669665
    Other Study ID Numbers:
    • SLS-002-201
    First Posted:
    Dec 17, 2020
    Last Update Posted:
    Jul 27, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Keywords provided by Seelos Therapeutics, Inc.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 27, 2022