Department of Defense PTSD Adaptive Platform Trial - Intervention D - SLS-002
NCT ID: NCT06816433
Last Updated: 2025-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
PHASE2
200 participants
INTERVENTIONAL
2025-11-30
2026-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Department of Defense PTSD Adaptive Platform Trial - Master Protocol
NCT05422612
Department of Defense PTSD Adaptive Platform Trial - Intervention A - Fluoxetine
NCT05948553
Department of Defense PTSD Adaptive Platform Trial - Intervention B - Vilazodone
NCT05948579
Open Label Extension Safety and Efficacy Study of TNX-102 SL Tablets in Military Related PTSD and Related Conditions
NCT02421679
Safety Study of Riluzole to Treat Post-traumatic Stress Disorder (PTSD)
NCT02155829
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Once a participant meets all eligibility criteria for the Master Protocol, eligibility for each currently enrolling intervention cohort is assessed. Eligible participants will be randomized with equal probability into a cohort. Participants randomized to the SLS-002 cohort are then randomly assigned to receive either SLS-002 or placebo (in a ratio of 5:3; intervention:placebo), for the duration of the 12-week treatment period.
Parties interested in having their intervention considered for testing within the Military and Veterans PTSD Adaptive Platform Clinical Trial (M-PACT) should complete a request for information form using this webpage https://citeline.qualtrics.com/jfe/form/SV\_8eTQKw6TNug4z42.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
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).
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention D: SLS-002
Intervention D SLS-002
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.
Intervention D: Placebo
Intervention D Placebo
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Intervention D SLS-002
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.
Intervention D Placebo
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
U.S. Army Medical Research and Development Command
FED
PPD Development, LP
INDUSTRY
Berry Consultants
OTHER
Idorsia Pharmaceuticals Ltd.
INDUSTRY
Cambridge Cognition Ltd
INDUSTRY
Citeline
INDUSTRY
Global Coalition for Adaptive Research
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Please visit the website:
Role: CONTACT
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Dr. Shabnam Thompson
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
S-21-02 (SLS-002)
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.