{"protocolSection":{"identificationModule":{"nctId":"NCT04468360","orgStudyIdInfo":{"id":"H-40643"},"secondaryIdInfos":[{"id":"R01MH122867","type":"NIH","link":"https://reporter.nih.gov/quickSearch/R01MH122867"}],"organization":{"fullName":"Boston University","class":"OTHER"},"briefTitle":"Pharmacokinetic Study for IV Allopregnanolone","officialTitle":"Facilitation of Extinction Retention and Reconsolidation Blockade by IV Allopregnanolone in PTSD- Pharmacokinetic Studies"},"statusModule":{"statusVerifiedDate":"2026-05","overallStatus":"TERMINATED","whyStopped":"The investigator moved to another institution; only preliminary data from pharmacokinetic studies were collected at Boston University School of Medicine/Boston Medical Center.","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2022-03-04","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2025-04-29","type":"ACTUAL"},"completionDateStruct":{"date":"2025-04-29","type":"ACTUAL"},"studyFirstSubmitDate":"2020-07-08","studyFirstSubmitQcDate":"2020-07-08","studyFirstPostDateStruct":{"date":"2020-07-13","type":"ACTUAL"},"resultsFirstSubmitDate":"2026-03-06","resultsFirstSubmitQcDate":"2026-05-29","resultsFirstPostDateStruct":{"date":"2026-06-02","type":"ACTUAL"},"lastUpdateSubmitDate":"2026-05-29","lastUpdatePostDateStruct":{"date":"2026-06-02","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Ann M Rasmusson","investigatorTitle":"Principal investigator","investigatorAffiliation":"Boston University"},"leadSponsor":{"name":"Boston University","class":"OTHER"},"collaborators":[{"name":"National Institute of Mental Health (NIMH)","class":"NIH"}]},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false,"isUsExport":true},"descriptionModule":{"briefSummary":"About 6.4% of the U.S. population suffers from posttraumatic stress disorder (PTSD). Trauma-focused psychotherapies are generally effective in PTSD, but responses vary greatly across individuals and PTSD subpopulations. Neurobiological factors impacted by life experiences, stress, and genetics can affect treatment responses. These factors can alter brain capacities needed to reprocess traumatic memories to prevent them from triggering intense, distressing, disruptive, out-of-place responses.\n\nBefore starting the interventional study (described in detail in NCT07079761), the investigators will conduct two pharmacokinetic (PK) studies (PK-1 and PK-2) in a small group of individuals with PTSD to test dosing and safety at Boston Medical Center."},"conditionsModule":{"conditions":["Pharmacokinetic Study","Post Traumatic Stress Disorder"],"keywords":["Pharmacokinetic study","Allopregnanolone (Allo)","Vital signs","Sedation ratings","Pulse oximeter data"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","primaryPurpose":"OTHER","maskingInfo":{"masking":"NONE","maskingDescription":"These pharmacokinetic (PK) studies are open-label studies confirming the dosing and safety of dosing for the main studies in NCT07079761."}},"enrollmentInfo":{"count":11,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"PK-1 Group","type":"EXPERIMENTAL","description":"Participants assigned to this group received IV allopregnanolone as a 5-minute loading dose at 1.7 mcg/kg followed by a maintenance infusion at 2.6 mcg/kg/hr over the next 4-5 hours intended to optimize resting plasma allopregnanolone + pregnanolone levels while outcomes were measured.","interventionNames":["Drug: PK-1 Good Manufacturing Practices (GMP) allopregnanolone (Allo) with Dexolve in 0.9% saline for infusion manufactured by the University of California, Davis"]},{"label":"PK-2 Group","type":"EXPERIMENTAL","description":"Participants assigned to this group received a 30-minute drug infusion of IV allopregnanolone of 28 mcg/kg, The IV allopregnanolone then was discontinued and only normal saline was continued for the next 4-5 hours while outcomes were measured.","interventionNames":["Drug: PK-2 GMP allopregnanolone (Allo) with Dexolve in 0.9% saline for infusion manufactured by the University of California, Davis."]}],"interventions":[{"type":"DRUG","name":"PK-1 Good Manufacturing Practices (GMP) allopregnanolone (Allo) with Dexolve in 0.9% saline for infusion manufactured by the University of California, Davis","description":"For the PK-1 group, after the 5-minute loading dose of IV allopregnanolone, the dose was changed as prescribed to optimize the subject's target plasma allopregnanolone + pregnanolone level for the next 4-5 hours.","armGroupLabels":["PK-1 Group"],"otherNames":["U.S.P. equivalent: brexanolone (IV Allopregnanolone with Captisol) (SAGE Therapeutics)"]},{"type":"DRUG","name":"PK-2 GMP allopregnanolone (Allo) with Dexolve in 0.9% saline for infusion manufactured by the University of California, Davis.","description":"For the PK-2 group, after the 30-minute drug infusion of IV allopregnanolone, the IV allopregnanolone was discontinued and only normal saline was continued for the next 4-5 hours.","armGroupLabels":["PK-2 Group"],"otherNames":["U.S.P. equivalent: brexanolone (IV allopregnanolone with Captisol) (SAGE Therapeutics)"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Clinician Assessed Sedation Levels for Each Participant","description":"Sedation levels will be assessed with the Qualitative Sedation Rating Scale. It has 5 categories: None- responds normally to verbal commands, cognitive \\& coordination not impaired, ventilatory \\& cardiovascular functions unaffected; Minimal- responds normally to verbal commands, unaffected ventilatory \\& cardiovascular functions, mild feelings of intoxication, cognitive function \\& coordination may be impaired; Moderate-responds purposefully to commands alone or with light touch, protective airway reflexes \\& adequate ventilation maintained without intervention, cardiovascular function remains stable; Deep- cannot be easily aroused but responds purposefully to noxious stimulation, assistance may be needed to ensure the airway is protected \\& adequate ventilation maintained, cardiovascular function is usually stable; Dissociative- trance-like cataleptic state with profound analgesia \\& amnesia, airway protective reflexes, spontaneous respirations \\& cardiopulmonary stability retained.","timeFrame":"resting pre-infusion; after loading dose at 0 minutes, 15 minutes, 30 minutes, 60 minutes, 120 minutes, and 300 minutes"},{"measure":"Blood Oxygen Saturation","description":"Average across participants of blood oxygen saturation levels obtained via pulse oximetry (ranging from 0% to 100%) for each time point indicated.","timeFrame":"resting pre-infusion; after loading dose at 0 minutes, 15 minutes, 30 minutes, 60 minutes, 120 minutes, and 300 minutes"},{"measure":"Respiratory Rate","description":"Average across participants of respiratory rate for each time point indicated.","timeFrame":"resting pre-infusion; after loading dose at 0 minutes, 15 minutes, 30 minutes, 60 minutes, 120 minutes, and 300 minutes"},{"measure":"Pulse Rate","description":"Average across participants of pulse rate for each time point indicated.","timeFrame":"resting pre-infusion; after loading dose at 0 minutes, 15 minutes, 30 minutes, 60 minutes, 120 minutes, and 300 minutes"},{"measure":"Diastolic Blood Pressure","description":"Average across participants of diastolic blood pressure for each time point indicated.","timeFrame":"resting pre-infusion; after loading dose at 0 minutes, 15 minutes, 30 minutes, 60 minutes, 120 minutes, and 300 minutes"},{"measure":"Systolic Blood Pressure","description":"Average across participants of systolic blood pressure for each time point indicated.","timeFrame":"resting pre-infusion; after loading dose at 0 minutes, 15 minutes, 30 minutes, 60 minutes, 120 minutes, and 300 minutes"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Chronic Posttraumatic Stress Disorder\n* Generally healthy and not on any prohibited medications (that could affect study outcomes)\n* Willing to abstain from alcohol for 2 weeks and from nicotine, marijuana or illicit drugs for 4 weeks before experimental procedures and throughout the study\n* Females: must have a menstrual cycle and not be on hormonal birth control (with a few exceptions; see below)\n* If gender non-conforming: must not be on hormone therapy\n\nExclusion Criteria:\n\n* Bipolar I disorder, schizophreniform disorder, or clinically significant psychotic symptoms apart from the presence of trauma-related sensory hallucinations or negative beliefs\n* Moderate or severe substance use disorder within three months of screening\n* Sleep Apnea\n* History of a suicide attempt within 1 year of enrolling\n* Imminent risk to self or others or requiring clinical intervention to maintain safety\n* Unstable medical condition or condition that may affect outcomes\n* Moderate or severe traumatic brain injury (TBI) (mild TBI acceptable; moderate TBI allowed for PK study)\n* Using any medications or substances (per self-report or toxicology testing) that may increase the risk for IV Allo side effects or affect the experimental results.\n* Unable to tolerate IV placement or blood drawing by needle stick\n* Wear hearing aids or fail hearing test (not applicable to PK study)\n* Females: pregnant, breastfeeding, or if of childbearing potential, unwilling to use two forms of effective birth control \\[except for hormonal contraceptives, unless intrauterine device (IUD) or a device like NuvaRing\\] for one week before and one month after study drug administration","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"55 Years","stdAges":["ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Ann M Rasmusson, MD","affiliation":"Boston University Chobanian & Avedisian School of Medicine, Dept of Psychiatry","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Boston University Chobanian & Avedisian School of Medicine","city":"Boston","state":"Massachusetts","zip":"02118","country":"United States","geoPoint":{"lat":42.35843,"lon":-71.05977}}]},"referencesModule":{"references":[{"pmid":"29325446","type":"BACKGROUND","citation":"Brunet A, Saumier D, Liu A, Streiner DL, Tremblay J, Pitman RK. Reduction of PTSD Symptoms With Pre-Reactivation Propranolol Therapy: A Randomized Controlled Trial. Am J Psychiatry. 2018 May 1;175(5):427-433. doi: 10.1176/appi.ajp.2017.17050481. Epub 2018 Jan 12."},{"pmid":"15501585","type":"BACKGROUND","citation":"Debiec J, Ledoux JE. Disruption of reconsolidation but not consolidation of auditory fear conditioning by noradrenergic blockade in the amygdala. Neuroscience. 2004;129(2):267-72. doi: 10.1016/j.neuroscience.2004.08.018."},{"pmid":"30782974","type":"BACKGROUND","citation":"Dunsmoor JE, Kroes MCW, Li J, Daw ND, Simpson HB, Phelps EA. Role of Human Ventromedial Prefrontal Cortex in Learning and Recall of Enhanced Extinction. J Neurosci. 2019 Apr 24;39(17):3264-3276. doi: 10.1523/JNEUROSCI.2713-18.2019. Epub 2019 Feb 19."},{"pmid":"29792441","type":"BACKGROUND","citation":"Elsey JWB, Van Ast VA, Kindt M. Human memory reconsolidation: A guiding framework and critical review of the evidence. Psychol Bull. 2018 Aug;144(8):797-848. doi: 10.1037/bul0000152. Epub 2018 May 24."},{"pmid":"22502987","type":"BACKGROUND","citation":"Glover EM, Jovanovic T, Mercer KB, Kerley K, Bradley B, Ressler KJ, Norrholm SD. Estrogen levels are associated with extinction deficits in women with posttraumatic stress disorder. Biol Psychiatry. 2012 Jul 1;72(1):19-24. doi: 10.1016/j.biopsych.2012.02.031. Epub 2012 Apr 12."},{"pmid":"17923095","type":"BACKGROUND","citation":"Hu H, Real E, Takamiya K, Kang MG, Ledoux J, Huganir RL, Malinow R. Emotion enhances learning via norepinephrine regulation of AMPA-receptor trafficking. Cell. 2007 Oct 5;131(1):160-73. doi: 10.1016/j.cell.2007.09.017."},{"pmid":"21377482","type":"BACKGROUND","citation":"Jovanovic T, Kazama A, Bachevalier J, Davis M. Impaired safety signal learning may be a biomarker of PTSD. Neuropharmacology. 2012 Feb;62(2):695-704. doi: 10.1016/j.neuropharm.2011.02.023. Epub 2011 Mar 4."},{"pmid":"19144840","type":"BACKGROUND","citation":"Mamiya N, Fukushima H, Suzuki A, Matsuyama Z, Homma S, Frankland PW, Kida S. Brain region-specific gene expression activation required for reconsolidation and extinction of contextual fear memory. J Neurosci. 2009 Jan 14;29(2):402-13. doi: 10.1523/JNEUROSCI.4639-08.2009."},{"pmid":"25312830","type":"BACKGROUND","citation":"Maren S. Out with the old and in with the new: Synaptic mechanisms of extinction in the amygdala. Brain Res. 2015 Sep 24;1621:231-8. doi: 10.1016/j.brainres.2014.10.010. Epub 2014 Oct 12."},{"pmid":"18313695","type":"BACKGROUND","citation":"Milad MR, Orr SP, Lasko NB, Chang Y, Rauch SL, Pitman RK. Presence and acquired origin of reduced recall for fear extinction in PTSD: results of a twin study. J Psychiatr Res. 2008 Jun;42(7):515-20. doi: 10.1016/j.jpsychires.2008.01.017. Epub 2008 Feb 29."},{"pmid":"20412837","type":"BACKGROUND","citation":"Milad MR, Zeidan MA, Contero A, Pitman RK, Klibanski A, Rauch SL, Goldstein JM. The influence of gonadal hormones on conditioned fear extinction in healthy humans. Neuroscience. 2010 Jul 14;168(3):652-8. doi: 10.1016/j.neuroscience.2010.04.030. Epub 2010 Apr 22."},{"pmid":"19342552","type":"BACKGROUND","citation":"Monfils MH, Cowansage KK, Klann E, LeDoux JE. Extinction-reconsolidation boundaries: key to persistent attenuation of fear memories. Science. 2009 May 15;324(5929):951-5. doi: 10.1126/science.1167975. Epub 2009 Apr 2."},{"pmid":"10963596","type":"BACKGROUND","citation":"Nader K, Schafe GE, Le Doux JE. Fear memories require protein synthesis in the amygdala for reconsolidation after retrieval. Nature. 2000 Aug 17;406(6797):722-6. doi: 10.1038/35021052."},{"pmid":"22125516","type":"BACKGROUND","citation":"Norrholm SD, Anderson KM, Olin IW, Jovanovic T, Kwon C, Warren VT, McCarthy A, Bosshardt L, Sabree J, Duncan EJ, Rothbaum BO, Bradley B. Versatility of fear-potentiated startle paradigms for assessing human conditioned fear extinction and return of fear. Front Behav Neurosci. 2011 Nov 21;5:77. doi: 10.3389/fnbeh.2011.00077. eCollection 2011."},{"pmid":"21035787","type":"BACKGROUND","citation":"Norrholm SD, Jovanovic T, Olin IW, Sands LA, Karapanou I, Bradley B, Ressler KJ. Fear extinction in traumatized civilians with posttraumatic stress disorder: relation to symptom severity. Biol Psychiatry. 2011 Mar 15;69(6):556-63. doi: 10.1016/j.biopsych.2010.09.013. Epub 2010 Oct 29."},{"pmid":"16272153","type":"BACKGROUND","citation":"Oh MC, Derkach VA, Guire ES, Soderling TR. Extrasynaptic membrane trafficking regulated by GluR1 serine 845 phosphorylation primes AMPA receptors for long-term potentiation. J Biol Chem. 2006 Jan 13;281(2):752-8. doi: 10.1074/jbc.M509677200. Epub 2005 Nov 4."},{"pmid":"10895567","type":"BACKGROUND","citation":"Orr SP, Metzger LJ, Lasko NB, Macklin ML, Peri T, Pitman RK. De novo conditioning in trauma-exposed individuals with and without posttraumatic stress disorder. J Abnorm Psychol. 2000 May;109(2):290-8."},{"pmid":"16828533","type":"BACKGROUND","citation":"Orr SP, Milad MR, Metzger LJ, Lasko NB, Gilbertson MW, Pitman RK. Effects of beta blockade, PTSD diagnosis, and explicit threat on the extinction and retention of an aversively conditioned response. Biol Psychol. 2006 Oct;73(3):262-71. doi: 10.1016/j.biopsycho.2006.05.001. Epub 2006 Jul 7."},{"pmid":"26866677","type":"BACKGROUND","citation":"Pineles SL, Nillni YI, King MW, Patton SC, Bauer MR, Mostoufi SM, Gerber MR, Hauger R, Resick PA, Rasmusson AM, Orr SP. Extinction retention and the menstrual cycle: Different associations for women with posttraumatic stress disorder. J Abnorm Psychol. 2016 Apr;125(3):349-55. doi: 10.1037/abn0000138. Epub 2016 Feb 11."},{"pmid":"23047775","type":"BACKGROUND","citation":"Pitman RK, Rasmusson AM, Koenen KC, Shin LM, Orr SP, Gilbertson MW, Milad MR, Liberzon I. Biological studies of post-traumatic stress disorder. Nat Rev Neurosci. 2012 Nov;13(11):769-87. doi: 10.1038/nrn3339. Epub 2012 Oct 10."},{"pmid":"30019147","type":"BACKGROUND","citation":"Rasmusson AM, Pineles SL. Neurotransmitter, Peptide, and Steroid Hormone Abnormalities in PTSD: Biological Endophenotypes Relevant to Treatment. Curr Psychiatry Rep. 2018 Jul 17;20(7):52. doi: 10.1007/s11920-018-0908-9."},{"pmid":"16415868","type":"BACKGROUND","citation":"Tronson NC, Wiseman SL, Olausson P, Taylor JR. Bidirectional behavioral plasticity of memory reconsolidation depends on amygdalar protein kinase A. Nat Neurosci. 2006 Feb;9(2):167-9. doi: 10.1038/nn1628. Epub 2006 Jan 15."},{"pmid":"26744059","type":"BACKGROUND","citation":"Zuj DV, Palmer MA, Hsu CM, Nicholson EL, Cushing PJ, Gray KE, Felmingham KL. IMPAIRED FEAR EXTINCTION ASSOCIATED WITH PTSD INCREASES WITH HOURS-SINCE-WAKING. Depress Anxiety. 2016 Mar;33(3):203-10. doi: 10.1002/da.22463. Epub 2016 Jan 6."}],"seeAlsoLinks":[{"label":"Parent study","url":"https://clinicaltrials.gov/study/NCT07079761"}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"PK-1 Group","description":"Participants assigned to this group received IV allopregnanolone as a 5-minute loading dose at 1.7 mcg/kg followed by a maintenance infusion at 2.6 mcg/kg/hr over the next 4-5 hours intended to optimize resting plasma allopregnanolone + pregnanolone levels while outcomes were measured."},{"id":"FG001","title":"PK-2 Group","description":"Participants assigned to this group received a 30-minute drug infusion of IV allopregnanolone at a dose of 28 mcg/kg. The IV allopregnanolone then was discontinued and only normal saline was continued for the next 4-5 hours while outcomes were measured."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"5"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"5"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"PK-1 Group","description":"Participants assigned to this group received IV allopregnanolone as a 5-minute loading dose at 1.7 mcg/kg followed by a maintenance infusion at 2.6 mcg/kg/hr over the next 4-5 hours intended to optimize resting plasma allopregnanolone + pregnanolone levels while outcomes were measured."},{"id":"BG001","title":"PK-2 Group","description":"Participants assigned to this group received a 30-minute drug infusion of IV allopregnanolone at a dose of 28 mcg/kg. The IV allopregnanolone then was discontinued and only normal saline was continued for the next 4-5 hours while outcomes were measured."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"11"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"11"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"7"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"4"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"11"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"7"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"11"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Clinician Assessed Sedation Levels for Each Participant","description":"Sedation levels will be assessed with the Qualitative Sedation Rating Scale. It has 5 categories: None- responds normally to verbal commands, cognitive \\& coordination not impaired, ventilatory \\& cardiovascular functions unaffected; Minimal- responds normally to verbal commands, unaffected ventilatory \\& cardiovascular functions, mild feelings of intoxication, cognitive function \\& coordination may be impaired; Moderate-responds purposefully to commands alone or with light touch, protective airway reflexes \\& adequate ventilation maintained without intervention, cardiovascular function remains stable; Deep- cannot be easily aroused but responds purposefully to noxious stimulation, assistance may be needed to ensure the airway is protected \\& adequate ventilation maintained, cardiovascular function is usually stable; Dissociative- trance-like cataleptic state with profound analgesia \\& amnesia, airway protective reflexes, spontaneous respirations \\& cardiopulmonary stability retained.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"resting pre-infusion; after loading dose at 0 minutes, 15 minutes, 30 minutes, 60 minutes, 120 minutes, and 300 minutes","groups":[{"id":"OG000","title":"PK-1 Group","description":"Participants assigned to this group received IV allopregnanolone as a 5-minute loading dose at 1.7 mcg/kg followed by a maintenance infusion at 2.6 mcg/kg/hr over the next 4-5 hours intended to optimize resting plasma allopregnanolone + pregnanolone levels while outcomes were measured."},{"id":"OG001","title":"PK-2 Group","description":"Participants assigned to this group received a 30-minute drug infusion of IV allopregnanolone at a dose of 28 mcg/kg. The IV allopregnanolone then was discontinued and only normal saline was continued for the next 4-5 hours while outcomes were measured."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"5"}]}],"classes":[{"title":"Pre-infusion : None","categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"5"}]}]},{"title":"Pre-infusion : Minimal","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"Pre-infusion : Moderate","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"Pre-infusion : Deep","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"Pre-infusion : Dissociative","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"0 minutes after loading dose: None","categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"5"}]}]},{"title":"0 minutes after loading dose: Minimal","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"0 minutes after loading dose: Moderate","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"0 minutes after loading dose: Deep","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"0 minutes after loading dose: Dissociative","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"15 minutes after loading dose: None","categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"5"}]}]},{"title":"15 minutes after loading dose: Minimal","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"15 minutes after loading dose: Moderate","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"15 minutes after loading dose: Deep","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"15 minutes after loading dose: Dissociative","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"30 minutes after loading dose: None","categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"5"}]}]},{"title":"30 minutes after loading dose: Minimal","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"30 minutes after loading dose: Moderate","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"30 minutes after loading dose: Deep","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"30 minutes after loading dose: Dissociative","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"60 minutes after loading dose: None","categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"5"}]}]},{"title":"60 minutes after loading dose: Minimal","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"60 minutes after loading dose: Moderate","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"title":"60 minutes after loading dose: 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