Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2025-12-24 @ 4:43 PM
Study NCT ID:
NCT06767566
Status:
RECRUITING
Last Update Posted:
2025-04-17
First Post:
2024-11-21
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D019052', 'term': 'Depression, Postpartum'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007649', 'term': 'Ketamine'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '20 subjects will be cesarean delivery population 30 subjects will be Healthy Control population (N=15 nonpregnant female, N=15 male) Both groups will receive same intervention'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-14', 'studyFirstSubmitDate': '2024-11-21', 'studyFirstSubmitQcDate': '2025-01-08', 'lastUpdatePostDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maternal ketamine area under the curve (AUC)', 'timeFrame': '0 to 24 hours from initiation of ketamine infusion', 'description': 'Ketamine area under the plasma concentration-time curve (AUC 0-∞) (AUC, mcg\\*min/mL), which reflects the actual body exposure to ketamine after administration of ketamine.'}], 'secondaryOutcomes': [{'measure': 'Patient reported acceptability of any reported side effects', 'timeFrame': '0 to 24 hours after initiation of ketamine infusion', 'description': 'Proportion (%) of patient cohort reporting acceptability of ketamine infusion'}, {'measure': 'Pain area under the curve (AUC)', 'timeFrame': '0 to 24 hours after initiation of ketamine infusion', 'description': 'Pain score area under the curve (AUC) where pain scores are measured from 0 (no pain) to 10 (worst imaginable pain), for the duration of epidural analgesia.'}, {'measure': 'Depression scores (Peripartum)', 'timeFrame': 'Baseline to week 12 post-infusion', 'description': 'Depression scores as defined by the Edinburgh Postnatal Depression Scale (Peripartum Group), scale 0-30, measured among the peripartum cohort.'}, {'measure': 'Depression Scores (control)', 'timeFrame': 'Baseline to week 12 post-infusion', 'description': 'Depression scores as defined by the Patient Health Questionnaire (PHQ-9) (Control Group), scale 0-27, measured among the control nonperipartum cohort.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cesarean Delivery'], 'conditions': ['Pain', 'Postpartum Depression']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to identify pharmacokinetics of postpartum ketamine infusion. This study will assess ketamine kinetics and metabolism in this setting. Ketamine is expected to exert different kinetics during the physiologic state of post-pregnancy. The goal in conducting this study is to better understand the pharmacokinetics and pharmacodynamics of postpartum ketamine infusion. A secondary goal is to compare these kinetics to reproductive age matched controls and to assess sex differences in ketamine pharmacokinetics.\n\nThe peripartum group of this study will receive ketamine after cesarean delivery, while the control group will consist of non-pregnant female subjects and male subjects receiving the same infusion protocol.', 'detailedDescription': 'A lack of data on new pain treatments in pregnancy puts 1.2 million US women having cesarean delivery (CD) every year at risk for poor pain control, depressed mood, and poor recovery. Evidence of successful post-surgical pain management and rapid reduction of depressive symptoms render ketamine a great candidate for post-CD pain management and potential reduction of postpartum depression (PPD) symptomology. Knowledge gaps in ketamine pharmacokinetics (PK) in the postpartum period limit an informed approach to its use for postpartum analgesia and PPD mitigation strategies. Similarly, knowledge gaps about sex differences in ketamine PK limit understandings about potential heterogeneity of treatment effects. This study aims to better understand the pharmacokinetics and pharmacodynamics of ketamine in postpartum women. Secondarily, it will assess key differences in postpartum ketamine PK compared to non-pregnant female controls. Secondarily it will assess key sex differences in ketamine metabolism between male and female subjects.\n\nPeripartum females undergoing cesarean delivery will receive a ketamine infusion for 12 hours after cord clamping. Samples will be taken to characterize ketamine PK (primary objective). Healthy volunteer control females and males will receive the same ketamine infusion dosing schematic. Comparisons will be made between peripartum females and non-pregnant female controls, and between female and male controls (secondary objectives).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Peripartum Participants:\n\nInclusion Criteria\n\n* Cesarean delivery\n* Adults 18 years and older\n* Term delivery ≥ 37 weeks gestation anticipated at time of delivery\n* ASA PS 2 or 3\n* Able to provide informed consent\n* One of the following must be met for inclusion: Not planning to breastfeed OR ketamine use indicated for pain management plan.\n\nExclusion Criteria\n\n* Patient going under general anesthesia for cesarean delivery\n* Allergy to study medication (ketamine)\n* ASA PS 4 +\n* Contraindications to neuraxial anesthesia\n* Preterm delivery (\\<37 weeks gestation)\n* Anticipated fetal-neonatal complex care plan as indicated in the patient's chart\n* Patient history of ketamine or PCP abuse\n* Patient history of schizophrenia or psychosis\n* Patient history of liver or renal insufficiency\n* Patient history of uncontrolled hypertension, chest pain, arrhythmia, head trauma, or intracranial hypertension, uncontrolled hyperthyroidism, or other contraindications to ketamine\n* Participating in another pain or depression intervention trial\n* Undergoing hormonal or gender affirming therapies\n* Pre-eclampsia with severe features\n* Hemodynamic instability\n* Inability to participate in study procedures for any reason\n* Contraindicated medications use: oral antihypertensive medications (exclusion: hypertensive disorders of pregnancy), intravenous magnesium (exclusion: pre-eclampsia with severe features), ketamine/phencyclidine/psilocybins/any other psychedelics (exclusion: ketamine or PCP abuse), lithium/valproate/carbamazepine/lamotrigine/haloperidol/chlorpromazine/fluphenazine/aripiprazole/clozapine/other typical or atypical antipsychotic medications (exclusion: schizophrenia or psychosis)\n\nControl Participants\n\nInclusion Criteria\n\n* Age 18 years and older\n* Sex: Male or Female\n* Able to provide informed consent\n* ASA PS 1, 2, or 3\n\nExclusion Criteria\n\n* Allergy to study medication (ketamine)\n* ASA PS 4 +\n* Inability to participate in study procedures for any reason\n* Patient history of ketamine or PCP abuse\n* Patient history of schizophrenia or psychosis\n* Patient history of liver or renal insufficiency\n* Patient history of uncontrolled hypertension, chest pain, arrhythmia, head trauma, intracranial hypertension, uncontrolled hyperthyroidism, or other contraindications to ketamine\n* Participating in another pain or depression intervention trial\n* Hemodynamic instability\n* Pregnant or pregnant within the last 6 weeks\n* Unwilling to provide urine sample for pregnancy testing (female controls)\n* Undergoing hormonal or gender affirming therapies\n* Contraindicated medications use: ketamine, phencyclidine, psilocybins, or other psychedelics (exclusion: ketamine or PCP abuse), lithium/valproate/carbamazepine/lamotrigine/haloperidol/chlorpromazine/fluphenazine/aripiprazole/clozapine, or other typical or atypical antipsychotic medications (exclusion: schizophrenia or psychosis)"}, 'identificationModule': {'nctId': 'NCT06767566', 'acronym': 'PREPARE-2', 'briefTitle': 'Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery', 'orgStudyIdInfo': {'id': 'STUDY22100019'}, 'secondaryIdInfos': [{'id': 'R01MH134538', 'link': 'https://reporter.nih.gov/quickSearch/R01MH134538', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ketamine Infusion: Cesarean Delivery Population', 'description': 'Loading dose infusion for 1 hour followed immediately by maintenance dose infusion for 11 hours.', 'interventionNames': ['Drug: Ketamine (Ketalar)']}, {'type': 'EXPERIMENTAL', 'label': 'Ketamine Infusion: Healthy Control Population', 'description': 'Loading dose infusion for 1 hour followed immediately by maintenance dose infusion for 11 hours.', 'interventionNames': ['Drug: Ketamine (Ketalar)']}], 'interventions': [{'name': 'Ketamine (Ketalar)', 'type': 'DRUG', 'otherNames': ['0.18 mg/kg/1hr loading dose Ketamine'], 'description': 'Loading Dose: 0.18 mg/kg/hr x 1 hour; Maintenance Dose 0.05 mg/kg/hr x 11 hours', 'armGroupLabels': ['Ketamine Infusion: Cesarean Delivery Population', 'Ketamine Infusion: Healthy Control Population']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amy Monroe, MPH, MBA', 'role': 'CONTACT', 'email': 'monroeal@upmc.edu', 'phone': '412-623-6382'}, {'name': 'Alexandra Anderson, BS', 'role': 'CONTACT', 'email': 'andersonah2@upmc.edu', 'phone': '412-641-4154'}, {'name': 'Grace Lim, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Magee Womens Hospital of UPMC', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amy Monroe, MPH, MBA', 'role': 'CONTACT', 'email': 'monroeal@upmc.edu', 'phone': '412-623-6382'}, {'name': 'Alexandra Anderson, BS', 'role': 'CONTACT', 'email': 'andersonah2@upmc.edu', 'phone': '412-641-4154'}, {'name': 'Grace Lim, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UPMC Montefiore Clinical and Translational Research Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'centralContacts': [{'name': 'Amy Monroe, MPH, MBA', 'role': 'CONTACT', 'email': 'monroeal@upmc.edu', 'phone': '4126236382'}, {'name': 'Alexandra Anderson, BS', 'role': 'CONTACT', 'email': 'andersonah2@upmc.edu', 'phone': '4126414154'}], 'overallOfficials': [{'name': 'Grace Lim, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'timeFrame': 'Beginning with 3 months and ending at 5 years following article publication.', 'ipdSharing': 'YES', 'description': 'Deidentified data will be available for public benefit and knowledge. Items for uploading will include clinical measures, patient reported outcomes, psychometric testing data, sensory testing data, and all PK data. Technical protocols and any other data collected under this project will be shared upon request to allow others to perform secondary analyses.', 'accessCriteria': 'Researchers who propose a methodologically sound proposal may submit said proposals to limkg2@upmc.edu. To gain access to data, requestors will need to sign a data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Grace Lim, MD, MS', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': "Associate Professor, Chief Obstetric & Women's Anesthesiology", 'investigatorFullName': 'Grace Lim, MD, MS', 'investigatorAffiliation': 'University of Pittsburgh'}}}}