This is a Phase 2 randomized, double-blinded, placebo-controlled study that will evaluate multiple potential pharmacotherapeutic interventions for PTSD utilizing an adaptive platform trial design.
Intervention B - Vilazodone will assess the safety and efficacy of vilzodone in participants with PTSD.
Please see NCT05422612 for information on the S-21-02 Master Protocol.
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Parallel
Intervention B Vilazodone Hydrochloride (HCl)
DrugVilazodone HCl will be administered at 10 mg once daily for 7 days, followed by 20 mg for 7 days, followed by 40 mg for the remainder of the trial. There must be a minimum of 7 days between dosage increases. One reduction in dose due to tolerability will be allowed. After Week 8, dose reduction for tolerability is allowed, but dose increase is not allowed.
Intervention B Placebo
DrugA matching placebo will be administered at 10 to 40 mg daily in the same regimen as the intervention.
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.
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).
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.
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.
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.
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.
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Global Coalition for Adaptive Research
Lead sponsor
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
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