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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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ClinicalTrials.gov Identifier: NCT04669665
Recruitment Status : Recruiting
First Posted : December 17, 2020
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
Seelos Therapeutics, Inc.

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
Depressive Disorder, Major Suicidal 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 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.
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 : December 17, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

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 Name: 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




Primary Outcome Measures :
  1. Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at 24 Hours Post First Dose [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04669665


Contacts
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Contact: Tim Whitaker, MD 484-432-2434 Tim.whitaker@seelostx.com

Locations
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United States, California
Seelos Investigational Site Not yet recruiting
Culver City, California, United States, 90230
Contact       SLS002team@seelostx.com   
Seelos Investigational Site Recruiting
Glendale, California, United States, 91206
Contact       SLS002team@seelostx.com   
Seelos Investigational Site Not yet recruiting
Orange, California, United States, 92868
Contact       SLS002team@seelostx.com   
United States, Florida
Seelos Investigational Site Recruiting
Miami Lakes, Florida, United States, 33016
Contact       SLS002team@seelostx.com   
United States, Georgia
Seelos Investigational Site Recruiting
Atlanta, Georgia, United States, 30331
Contact       SLS002team@seelostx.com   
Seelos Investigational Site Recruiting
Decatur, Georgia, United States, 30030
Contact       SLS002team@seelostx.com   
United States, Maryland
Seelos Investigational Site Recruiting
Gaithersburg, Maryland, United States, 20877
Contact       SLS002team@seelostx.com   
United States, Ohio
Seelos Investigational Site Recruiting
North Canton, Ohio, United States, 44720
Contact       SLS002team@seelostx.com   
United States, Texas
Seelos Investigational Site Recruiting
Richardson, Texas, United States, 75080
Contact       SLS002team@seelostx.com   
Sponsors and Collaborators
Seelos Therapeutics, Inc.
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Responsible Party: Seelos Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04669665    
Other Study ID Numbers: SLS-002-201
First Posted: December 17, 2020    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.

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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
Keywords provided by Seelos Therapeutics, Inc.:
Depression
Depressive disorder
SLS-002
Mental disorders
Suicide
Suicidal Ideation
Mood disorders
Behavioral symptoms
Self-injurious behavior
Ketamine
Antidepressive agents
Psychotropic drugs
Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Suicide
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Self-Injurious Behavior
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action