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
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 发起方
- 入组人数
- 200
- 试验地点
- 19
- 主要终点
- Absolute change in the Clinician-Administered PTSD Scale-5-Revised (CAPS-5-R) Past Month total score at Week 12 (Final/Early termination Visit).
研究概览
简要总结
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 A - Fluoxetine will assess the safety and efficacy of fluoxetine in participants with PTSD.
Please see NCT05422612 for information on the S-21-02 Master Protocol.
详细描述
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 fluoxetine 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 fluoxetine cohort are then randomly assigned to receive either fluoxetine 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..
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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).
For this APT, participants 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).
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No additional inclusion criteria beyond the inclusion criteria specified in the Master Protocol (NCT05422612).
排除标准
- •The following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol (NCT05422612).
- •1. Recent history of treatment for PTSD with fluoxetine at doses of 20 mg daily, for at least 4 weeks. A remote history of treatment with fluoxetine for non-PTSD symptoms will be discussed on a case-by-case basis with the contract research organization (CRO) Medical Monitor.
研究组 & 干预措施
Intervention A: Fluoxetine HCl
干预措施: Intervention A Fluoxetine Hydrochloride (HCl) (Drug)
Intervention A Placebo
干预措施: Intervention A Placebo (Drug)
结局指标
主要结局
Absolute change in the Clinician-Administered PTSD Scale-5-Revised (CAPS-5-R) Past Month total score at Week 12 (Final/Early termination Visit).
时间窗: 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.
Incidence of new or worsening suicidal thoughts or behaviors as measured by change in Columbia Suicide Severity Rating Scale (C-SSRS) score from baseline.
时间窗: 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).
次要结局
- Frequency of treatment-emergent adverse events (TEAEs).(12 Weeks)
- Frequency of serious adverse events (SAEs).(12 Weeks)
- Severity of treatment-emergent adverse events (TEAEs).(12 Weeks)
- Severity of serious adverse events (SAEs).(12 Weeks)
- Number of participants with a Response Rate ≥30%(12 Weeks)
- Number of participants with a Response Rate ≥50%(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 Achieving Remission(12 Weeks)