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Not yet recruiting NCT05948579

Department of Defense PTSD Adaptive Platform Trial - Intervention B - Vilazodone

Phase II Interventional Post Traumatic Stress Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intervention B Vilazodone Hydrochloride (HCl), Intervention B Placebo.
Who it may be relevant to
Registry conditions: Post Traumatic Stress Disorder. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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, Veterans, and Non-Veteran Civilians With PTSD

Overview

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.

Interventions

  • Drug 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.
  • Drug Intervention B Placebo
    A matching placebo will be administered at 10 to 40 mg daily in the same regimen as the intervention.

Primary outcome measures

  • 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]
  • 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]
Secondary outcome measures (8)
  • Frequency of treatment-emergent adverse events (TEAEs). [Time frame: 12 Weeks]
  • Severity of treatment-emergent adverse events (TEAEs). [Time frame: 12 Weeks]
  • Frequency of serious adverse events (SAEs). [Time frame: 12 Weeks]
  • Severity of serious adverse events (SAEs). [Time frame: 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. [Time frame: 12 Weeks]
  • Number of participants with a Response Rate ≥30% [Time frame: 12 Weeks]
  • Number of participants with a Response Rate ≥50% [Time frame: 12 Weeks]
  • Number of participants Achieving Remission. [Time frame: 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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. PMID 37088912

Identifiers

NCT: NCT05948579 · S-21-02 (Vilazodone)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗