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

NCT06816433 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: S-21-02 (SLS-002)
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 10

Brief Summary

This is a Phase 2 randomized, double-blinded, placebo-controlled study that will evaluate multiple potential pharmacotherapeutic interventions for Post Traumatic Stress Disorder (PTSD) utilizing an adaptive platform trial (APT) design. Intervention D - SLS-002 will assess the safety and efficacy of SLS-002 in participants with PTSD. Please see NCT05422612 for information on the S-21-02 Master Protocol.

Conditions

Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (2)

• Absolute change in the Clinician-Administered PTSD Scale-5-Revised (CAPS-5-R) Past Month total score at Week 12 (Final/Early termination Visit).

  A change in PTSD symptom severity from baseline as measured by CAPS-5-R Past Month. The range of the scale is 0-200. The higher the score at baseline, the worse the PTSD severity. The larger the decrease in score from baseline, the better the outcome.

  12 Weeks

• Incidence of new or worsening suicidal thoughts or behaviors as measured by change in Columbia Suicide Severity Rating Scale (C-SSRS) score from baseline.

  The C-SSRS is an assessment of suicidal ideation and behavior in clinical and research settings. The C-SSRS consists of 16 questions that ask about suicidal ideation and behaviors (the first 10 questions comprise the ideation subscale and the last 6 comprise the behavior subscale). This 5-item subscale ranges from a minimum of 0 (corresponding to no suicidal ideation) to a maximum of 5 (representing active suicidal ideation with plan and intent).

  12 Weeks

Secondary Outcomes (8)

• Frequency of treatment-emergent adverse events (TEAEs).

  12 Weeks

• Severity of treatment-emergent adverse events (TEAEs).

  12 Weeks

• Frequency of serious adverse events (SAEs)

  12 Weeks

• Severity of serious adverse events (SAEs).

  12 Weeks

• Relative change from Baseline to Week 12 in CAPS-5-R, Past Month total score.

  12 Weeks

Study Arms (2)

Intervention D: SLS-002

EXPERIMENTAL

Drug: Intervention D SLS-002

Intervention D: Placebo

PLACEBO COMPARATOR

Drug: Intervention D Placebo

Interventions

Intervention D SLS-002 DRUG

SLS-002 will be administered via intranasal administration (one spray per nostril, per device) at 78 mg two times per week for the first eight weeks and then once a week for the last four weeks.

Also known as: Ketamine

Intervention D: SLS-002

Intervention D Placebo DRUG

A matching placebo will be administered via intranasal administration (one spray per nostril, per device) two times per week for the first eight weeks and then once a week for the last four weeks.

Intervention D: Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Participants who have undergone or plans to undergo gender reassignment surgery are not eligible. Participants who are currently undergoing stable hormone replacement therapy are eligible for inclusion in the study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Is able to complete intranasal administration of study intervention.
• Is able to refrain from alcohol or cannabis consumption/use on dosing days.
• 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.
• Has a history of seizures (other than childhood febrile seizures).
• Has a body mass index \>40 or \<18 kg/m2 at Screening.
• 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).
• 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.
• 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.
• 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).
• Has a history of interstitial or ulcerative cystitis, overactive bladder, painful bladder
• 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).
• Has any history of using ketamine or esketamine. Note previous use of ketamine for anesthesia is allowed.
• Has known or suspected intolerance or hypersensitivity to the study intervention(s), closely related compounds, or any ingredients.
• 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.

Sponsors & Collaborators

• Global Coalition for Adaptive Research: lead
• U.S. Army Medical Research and Development Command: collaborator
• PPD Development, LP: collaborator
• Berry Consultants: collaborator
• Idorsia Pharmaceuticals Ltd.: collaborator
• Cambridge Cognition Ltd: collaborator
• Citeline: collaborator

Study Sites (10)

Phoenix VA Healthcare System

Phoenix, Arizona, 85012-1839, United States

Location

Homestead Associates in Research, Inc.

Miami, Florida, 33032, United States

Location

Advanced Discovery Research

Atlanta, Georgia, 30318, United States

Location

Tripler Army Medical Center (TAMC)

Tripler AMC, Hawaii, 96859, United States

Location

Cincinnati Veteran's Affairs Medical Center

Fort Thomas, Kentucky, 41075, United States

Location

Walter Reed National Military Medical Center (WRNMC)

Bethesda, Maryland, 20889-5632, United States

Location

Upstate Clinical Research Associates, LLC

Williamsville, New York, 14221, United States

Location

Wilford Hall Ambulatory Surgical Center (WHASC)

San Antonio, Texas, 78236, United States

Location

Alexander T. Augusta Military Medical Center (ATAMMC):

Fort Belvoir, Virginia, 22060-5285, United States

Location

Madigan Army Medical Center

Joint Base Lewis McChord, Washington, 98433, United States

Location

Related Publications (1)

• Viele K. Allocation in platform trials to maintain comparability across time and eligibility. Stat Med. 2023 Jul 20;42(16):2811-2818. doi: 10.1002/sim.9750. Epub 2023 Apr 23.

  PMID: 37088912 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Please visit the website:

CONTACT

ptsdclinicaltrial.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The overall 2-stage randomization scheme will be implemented by an unblinded statistician who is otherwise uninvolved in study operations. Participants will be assigned a study number at Screening (Subject ID). In the first stage of randomization, eligible participants who complete screening will be randomly assigned to an open platform cohort for which they are eligible (both site PIs and participants are aware of the cohort assignment) and, within that cohort, the second stage of randomization is to intervention vs placebo (double-blind) using Interactive Response Technology (IRT). For this Adaptive Platform Trial (APT), participants assignment to a cohort will not be blinded. The devices used in this cohort may not be visually similar between cohorts and blinding to cohort assignment is not necessary to avoid bias. However, within each cohort, participants, site personnel, contract research personnel and the sponsor will be blind to treatment assignment (intervention vs. placebo).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: SLS-002 is one of multiple interventions that will be tested in this adaptive platform trial (NCT05422612).

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 10, 2025
• Study Start: November 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 8, 2025

Record last verified: 2025-03

Locations

US (10)