Clinical trial
A Phase 2, Multi-center, Multi-arm, Randomized, Placebo-controlled, Double-blind, Adaptive Platform Study to Evaluate the Safety, Tolerability, and Efficacy of Potential Pharmacotherapeutic Interventions in Active-Duty Service Members and Veterans With PTSD
Name
S-21-02 (Vilazodone)
Description
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.
Trial arms
Trial start
2024-03-01
Estimated PCD
2026-03-01
Trial end
2026-09-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
Intervention B Vilazodone Hydrochloride (HCl)
Vilazodone 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.
Arms:
Intervention B Vilazodone
Intervention B Placebo
A matching placebo will be administered at 10 to 40 mg daily in the same regimen as the intervention.
Arms:
Intervention B Placebo
Size
200
Primary endpoint
Absolute change in the Clinician-Administered PTSD Scale-5-Revised (CAPS-5-R) Past Month total score at Week 12 (Final/Early termination Visit).
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.
12 Weeks
Eligibility criteria
Inclusion Criteria:
No additional inclusion criteria beyond the inclusion criteria specified in the Master Protocol (NCT05422612).
Exclusion Criteria:
The following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol (NCT05422612).
1. History of treatment for PTSD with vilazodone at doses of 20 to 40 mg daily, for at least 4 weeks.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Vilazodone is one of multiple interventions that will be tested in this adaptive platform trial (NCT05422612).', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': '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).\n\nFor this APT, participant assignment to a cohort will not be blinded. The tablets/capsules used in the cohorts 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).', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}
Updated at
2024-01-29
1 organization
2 products
1 indication
Product
B VilazodoneIndication
Post-Traumatic Stress DisorderProduct
Intervention B