2021
Design of the national adaptive trial for PTSD-related insomnia (NAP study), VA cooperative study program (CSP) #2016
Krystal JH, Chow B, Vessicchio J, Henrie AM, Neylan TC, Krystal AD, Marx BP, Xu K, Jindal RD, Davis LL, Schnurr PP, Stein MB, Thase ME, Ventura B, Huang GD, Shih MC, Team T. Design of the national adaptive trial for PTSD-related insomnia (NAP study), VA cooperative study program (CSP) #2016. Contemporary Clinical Trials 2021, 109: 106540. PMID: 34416369, DOI: 10.1016/j.cct.2021.106540.Peer-Reviewed Original ResearchConceptsCooperative Studies ProgramInsomnia medicationsMedical CenterRandomized placebo-controlled clinical trialPlacebo-controlled clinical trialVeterans Affairs Medical CenterVA Cooperative Studies ProgramPrimary outcome measureVA Medical CenterInsomnia Severity IndexAdaptive trialsPosttraumatic stress disorderFuture biomarker developmentStudy armsBiochemical predictorsEffective pharmacotherapyClinical trialsOutcome measuresTreatment responseInterim analysisRecruitment targetInsomniaPhone contactStress disorderBiomarker development
2019
Repeated ketamine infusions for antidepressant-resistant PTSD: Methods of a multicenter, randomized, placebo-controlled clinical trial
Abdallah CG, Roache JD, Averill LA, Young-McCaughan S, Martini B, Gueorguieva R, Amoroso T, Southwick SM, Guthmiller K, López-Roca AL, Lautenschlager K, Mintz J, Litz BT, Williamson DE, Keane TM, Peterson AL, Krystal JH, PTSD F. Repeated ketamine infusions for antidepressant-resistant PTSD: Methods of a multicenter, randomized, placebo-controlled clinical trial. Contemporary Clinical Trials 2019, 81: 11-18. PMID: 30999057, DOI: 10.1016/j.cct.2019.04.009.Peer-Reviewed Original ResearchConceptsPosttraumatic stress disorderStudy drugClinical trialsTherapeutic effectPharmacotherapy of PTSDFirst placebo-controlled trialPlacebo-controlled clinical trialActive duty military populationDose-related efficacyMedication treatment optionsPlacebo-controlled trialDose-related effectsNovel neural mechanismActive duty militaryKetamine infusionSerotonergic antidepressantsEligible participantsTreatment optionsCase reportNew drug developmentOnly trialSustained reductionVeteran populationDrug AdministrationPilot evidence