Clinical TrialMajor Depressive Disorder (MDD)KetaminePlaceboCompleted

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

Randomized, double-blind (Part 2) placebo-controlled Phase II study (n=164 actual) of intranasal SLS-002 (90 mg, twice weekly for 2 weeks; 4 doses) plus standard of care versus placebo plus standard of care in adults with MDD at imminent risk of suicide.

Target Enrollment
164 participants
Study Type
Phase II interventional
Design
Randomized, quadruple Blind

Detailed Description

Two-part study: Part 1 open-label; Part 2 randomized, double-blind, placebo-controlled, parallel-group comparing SLS-002 plus standard of care to intranasal placebo plus standard of care.

Primary outcome is change from baseline in MADRS total score at 24 hours post first dose; safety, tolerability, and suicidality measures are assessed throughout with hospitalisation and clinician-rated instruments used for entry criteria and follow-up.

Dosing regimen in Part 2 is 90 mg intranasal racemic ketamine delivered via device two times per week for 2 weeks (4 total administrations), given with concomitant standard of care determined by treating clinicians.

Study Protocol

Preparation

sessions

Dosing

4 sessions

Integration

sessions

Study Arms & Interventions

SLS-002 + SOC

experimental

Intranasal SLS-002 plus standard of care; 90 mg intranasal dosing two times per week for 2 weeks.

Interventions

  • Ketamine90 mg
    via Other• twice weekly• 4 doses total

    Intranasal racemic ketamine delivered via intranasal device; 90 mg per administration.

  • Compound
    via Other• concomitant

    Standard of care (treatment determined by treating physician).

Placebo + SOC

inactive

Intranasal placebo plus standard of care; matched schedule.

Interventions

  • Placebo
    via Other• twice weekly• 4 doses total

    Intranasal placebo via device.

  • Compound
    via Other• concomitant

    Standard of care (treatment determined by treating physician).

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Participant with diagnosis of current MDD (unipolar without psychotic features) per DSM-5, with symptoms present for at least 4 weeks, based on psychiatric intake and confirmed by the 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 hospitalisation 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 judgement 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 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

  • 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 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.

Study Details

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

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