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
Overview
- Phase
- Phase 2
- Intervention
- Intervention B Vilazodone Hydrochloride (HCl)
- Conditions
- Post Traumatic Stress Disorder
- Sponsor
- Global Coalition for Adaptive Research
- Enrollment
- 200
- Primary Endpoint
- Incidence of new or worsening suicidal thoughts or behaviors as measured by change in Columbia Suicide Severity Rating Scale (C-SSRS) score from baseline.
- Status
- Not yet recruiting
- Last Updated
- 7 months ago
Overview
Brief Summary
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.
Detailed Description
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 vilazodone 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 vilazodone cohort are then randomly assigned to receive either vilazodone 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 M-PACT should complete a request for information form using this webpage https://citeline.qualtrics.com/jfe/form/SV\_8eTQKw6TNug4z42.
Investigators
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.
Arms & Interventions
Intervention B Vilazodone
Intervention: Intervention B Vilazodone Hydrochloride (HCl)
Intervention B Placebo
Intervention: Intervention B Placebo
Outcomes
Primary Outcomes
Incidence of new or worsening suicidal thoughts or behaviors as measured by change in Columbia Suicide Severity Rating Scale (C-SSRS) score from baseline.
Time Frame: 12 Weeks
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).
Absolute change in the Clinician-Administered PTSD Scale-5-Revised (CAPS-5-R) Past Month total score at Week 12 (Final/Early termination Visit).
Time Frame: 12 Weeks
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.
Secondary Outcomes
- 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 the Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R), Past Month total score.(12 Weeks)
- Number of participants with a Response Rate ≥30%(12 Weeks)
- Number of participants with a Response Rate ≥50%(12 Weeks)
- Number of participants Achieving Remission.(12 Weeks)