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Suspended
NCT05422612
Department of Defense PTSD Adaptive Platform Trial - Master Protocol
Conditions: Post Traumatic Stress Disorder
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: Yes
Phase: PHASE2
Enrollment: 800
Sponsor: Global Coalition for Adaptive Research
Location: Homestead Associates in Research, Inc. Miami Florida
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. 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.
Eligibility Criteria
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 \450 msec for males or \>470 msec for females (QT interval corrected with Fridericia correction \[QTcF\]) At Screening, eligibility will be based on the central ECG reading. At Baseline, eligibility will be based on the local ECG reading by a site investigator.
11. Has abnormal laboratory results at the Screening Visit:
1. serum creatinine \>1.5 mg/dL OR
2. estimated creatinine clearance of \2 × ULN
2. total bilirubin level \>1.5 × ULN (unless previously known Gilbert syndrome)
3. prolonged prothrombin time \>1.5 × ULN
13. Has a prior history of drug induced liver injury characterized by ALT or AST \>3 × ULN AND total bilirubin level \>2 × ULN without cholestasis (ie, ALP \140 mm Hg and/or diastolic blood pressure \>90 mm Hg or Systolic blood pressure \
Source: ClinicalTrials.gov (NCT05422612). StuddyBuddy aggregates publicly available trial information.