Clinical TrialPTSDKetaminePlaceboNot yet recruiting

Department of Defense PTSD Adaptive Platform Trial – Intervention D – SLS-002

This Phase II randomised, quadruple-blind, placebo-controlled trial (n=200) will assess the safety and efficacy of intranasal SLS-002 (ketamine, 78mg) for post-traumatic stress disorder (PTSD) in active-duty service members and veterans.

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

Detailed Description

Adaptive platform, Phase II, randomized study comparing intranasal SLS-002 (78 mg per administration) to placebo over a 12-week treatment period in participants with PTSD.

Dosing schedule: twice weekly for the first 8 weeks, then once weekly for Weeks 9–12 (total 20 administrations); primary analyses compare intervention vs pooled placebo control within the master adaptive platform.

Outcome and safety assessments follow the Master Protocol (NCT05422612) with a 30-day screening period and 4-week safety follow-up after treatment.

Study Protocol

Preparation

sessions

Dosing

20 sessions

Integration

sessions

Study Arms & Interventions

SLS-002

experimental

Intranasal SLS-002 (ketamine) administered on a 12-week schedule.

Interventions

  • Ketamine78 mg
    via Other• twice weekly for 8 weeks then once weekly for 4 weeks• 20 doses total

    Intranasal — one spray per nostril (78 mg) per administration.

Placebo

inactive

Matching intranasal placebo with identical dosing schedule.

Interventions

  • Placebo
    via Other• twice weekly for 8 weeks then once weekly for 4 weeks• 20 doses total

    Matching intranasal placebo; one spray per nostril per administration.

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • The following inclusion criteria are in addition to the exclusion criteria specified in the Master Protocol (NCT05422612).
  • 1. Is able to complete intranasal administration of study intervention.
  • 2. Is able to refrain from alcohol or cannabis consumption/use on dosing days.
  • 3. Is willing and able to attend dosing visits as outlined in the protocol (twice a week for the first 8 week and then once a week for Weeks 9 through 12) and agrees not to drive a car or operate machinery for 24 hours after receiving the study intervention.

Exclusion Criteria

  • Exclusion Criteria:
  • The following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol (NCT05422612).
  • 1. Has a history of seizures (other than childhood febrile seizures).
  • 2. Has a body mass index >40 or <18 kg/m2 at Screening.
  • 3. Has known, uncontrolled hypertension or blood pressure that, in the investigator's judgment, should exclude the subject at Screening or Baseline (blood pressure may be repeated as per the site's standard operating procedures).
  • 4. Has a known history or current finding of cardiovascular disease, cerebrovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, congenital heart disease, ischemic heart disease, cardiac insufficiency, supraventricular, ventricular heart rhythm disorder, prolonged QT syndrome (ie, QTcF >450 msec for males and >470 msec for females) or associated risk factors (ie, hypokalemia, family history of long QT syndrome), syncope, cardiac conduction problems (eg, clinically significant heart block), exercise-related cardiac events including syncope and pre-syncope, clinically significant bradycardia, or other serious cardiac problems.
  • 5. Has a concurrent chronic or acute illness, or other condition (eg, narcolepsy, uncontrolled hyper- or hypothyroidism) that might confound the results of safety assessments conducted in the study.
  • 6. Has any medical condition that could interfere with the absorption of intranasal ketamine (eg, nasal polyps, clinically significant deviated septum [corrected or persistent], or other physical abnormalities of the nose).
  • 7. Has a history of interstitial or ulcerative cystitis, overactive bladder, painful bladder
  • 8. syndrome, chronic pelvic pain, frequent recurrent urinary tract infections, autoimmune disease, active urinary tract infection, history of prostate cancer, bladder cancer or bladder
  • a. surgery, or symptoms suggestive of these disorders (eg, high urinary frequency, persistent urge to urinate).
  • 9. Has any history of using ketamine or esketamine. Note previous use of ketamine for anesthesia is allowed.
  • 10. Has known or suspected intolerance or hypersensitivity to the study intervention(s), closely related compounds, or any ingredients.
  • 11. Does not meet or is not willing to comply with the requirements listed in protocol related to prohibited and restricted medications and therapies, as well as required washout periods prior to participation. Prohibited medications and therapies include, but are not limited to, monoamine oxidase inhibitors (MAOIs), chronic/frequent use of opioids or drugs with activity at the opioid receptor, psychostimulants, mood stabilizers/anticonvulsants, antipsychotics, or any medication/therapy that might confound the results of safety assessments conducted in the study. Subjects who have received any of these prohibited medications within 30 days of Screening are excluded from the study. Potent CYP 3A4 inhibitors, including nefazodone and fluvoxamine, are not permitted within 1 week of first dose and until at least 1 day after the last dose. Potent CYP 3A4 inducers, including a. St. John's wort, are not permitted within 30 days of first dose and until at least 1 day after the last dose.

Study Details

  • Status
    Not yet recruiting
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment200 participants
  • Timeline
    Start: 2025-06-01
    End: 2026-09-01
  • Compounds
    KetaminePlacebo
  • Topic
    PTSD

Locations

Phoenix VA Healthcare System — Phoenix, Arizona, United States
Homestead Associates in Research, Inc. — Miami, Florida, United States
Advanced Discovery Research — Atlanta, Georgia, United States
Tripler Army Medical Center (TAMC) — Tripler AMC, Hawaii, United States
Cincinnati Veteran's Affairs Medical Center — Fort Thomas, Kentucky, United States
Walter Reed National Military Medical Center (WRNMC) — Bethesda, Maryland, United States
Upstate Clinical Research Associates, LLC — Williamsville, New York, United States
Wilford Hall Ambulatory Surgical Center (WHASC) — San Antonio, Texas, United States
Alexander T. Augusta Military Medical Center (ATAMMC): — Fort Belvoir, Virginia, United States
Madigan Army Medical Center — Joint Base Lewis McChord, Washington, United States

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