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.
The general structure of this Adaptive Platform Trial (APT) consists of a 30-day Screening Period, a 12-week Platform Treatment Period, and a 4-week Safety Follow-up. The S-21-02 Platform Trial will evaluate the safety and efficacy of multiple investigational products for the treatment of PTSD (see NCT05422612 for Master Protocol information). Participants are randomized among the multiple cohorts in the study and the resulting randomization enables sharing/pooling of control subjects, where all interventions may be compared to a common control (placebo). This record only includes information relevant to the SLS-002 cohort. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
200
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.
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.
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
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.
Time frame: 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).
Time frame: 12 Weeks
Frequency of treatment-emergent adverse events (TEAEs).
The TEAEs recorded during the study will be summarized by system organ class, preferred term, and treatment group. Adverse events and medical history will be coded using the most current version of MedDRA.
Time frame: 12 Weeks
Severity of treatment-emergent adverse events (TEAEs).
The TEAEs recorded during the study will be summarized by system organ class, preferred term, and treatment group. Adverse events and medical history will be coded using the most current version of MedDRA.
Time frame: 12 Weeks
Frequency of serious adverse events (SAEs)
The SAEs recorded during the study will be summarized by system organ class, preferred term, and treatment group. Adverse events and medical history will be coded using the most current version of MedDRA
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
Time frame: 12 Weeks
Severity of serious adverse events (SAEs).
The SAEs recorded during the study will be summarized by system organ class, preferred term, and treatment group. Adverse events and medical history will be coded using the most current version of MedDRA
Time frame: 12 Weeks
Relative change from Baseline to Week 12 in CAPS-5-R, Past Month total score.
A relative change in PTSD symptom severity from baseline as measured by the Clinician-Administered PTSD Scale for DSM-5 Revised (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.
Time frame: 12 Weeks
Number of participants with a Response Rate ≥30%
≥30% reduction from Baseline to 12 Weeks in the Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R), Past Month total score. The range of the scale is 0-200. The higher the score, the worse the PTSD severity. The larger the decrease in score from baseline, the better the outcome.
Time frame: 12 Weeks
Number of participants with a Response Rate ≥50%
≥50% reduction from Baseline to 12 Weeks in the Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R), Past Month total score. The range of the scale is 0-200. The higher the score, the worse the PTSD severity. The larger the decrease in score from baseline, the better the outcome.
Time frame: 12 Weeks
Number of participants Achieving Remission.
Achieving remission: defined as the Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R), Past Month total score \<18. The range of the scale is 0-200. The higher the score, the worse the PTSD severity.
Time frame: 12 Weeks