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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Absolute change in the Clinician-Administered PTSD Scale-5-Revised (CAPS-5-R) Past Month total score at Week 12 (Final/Early termination Visit). [Срок оценки: 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. [Срок оценки: 12 Weeks]

Вторичные конечные точки (8)

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

Критерии участия

Критерии включения

No additional inclusion criteria beyond the inclusion criteria specified in the Master Protocol (NCT05422612).

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗