Global Coalition for Adaptive Research
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. Participants are randomized among the available cohorts in the study and the resulting randomization enables sharing/pooling of control participants, where all interventions may be compared to a common control (placebo). The master protocol describes the default procedures and analyses for all cohorts; treatment-specific eligibility requirements, safety and efficacy procedures, or endpoints are described in the cohort-specific appendices and reflected in the intervention-specific clinicaltrials.gov records.
The general structure of the M-PACT consists of a 30-day Screening Period, a 12-week Treatment Period, and a 4-week Safety Follow-up. The trial will include up to 5 open cohorts (it is possible for 1 of the cohorts to begin sooner than the others, as necessary). Importantly, the integration of multi-modal biomarker assessments within the M-PACT allows for defining future cohorts based on to be determined biomarker signatures in a multi stage approach. Initial testing in non biomarker defined cohorts will be referred to as "main stage" testing, while testing in biomarker-defined cohorts will oc…
Inclusion Criteria: An individual must meet all the following criteria to be eligible to participate in this study: 1. Is willing and able to provide written informed consent. 2. ≥18 and \<65 years of age at Screening. 3. Meets DSM-5 criteria for PTSD according to CAPS-5-R, Past Month assessment at Screening and Baseline. 4. The index trauma must have occurred more than 3 months prior to Screening. 5. Has a CAPS-5-R, Past Month total score of ≥26 at Screening and Baseline. Note: The CAPS-5 scoring grid will be used to score answers and to calculate the total score to determine eligibility. 6.…
Fluoxetine will be administered at 10 to 60 mg daily. The initial dose for all participants will be 10 mg daily for 1 week, then increased to 20 mg daily for 2 weeks, then increased to 40 mg daily for 2 weeks, then increased to 60 mg daily for the remainder of the trial. One reduction in dose due to tolerability will be allowed. When a participant's dose is decreased due to tolerability, the dose will not be increased.
A matching placebo will be administered at 10 to 60 mg daily in the same regimen as the intervention.
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.
A matching placebo will be administered at 10 to 40 mg daily in the same regimen as the intervention.
Daridorexant will be administered 50 mg once daily.
A matching placebo will be administered at 50 mg daily in the same regimen as the intervention.
• SLS-002 will be administered via intranasal administration (one spray per nostril, per device) at 78 mg two times per week for the first eight weeks and then once a week for the last four weeks.
A matching placebo will be administered via intranasal administration (one spray per nostril, per device) two times per week for the first eight weeks and then once a week for the last four weeks.