Ignite Creation Date:
2025-12-24 @ 12:01 PM
Ignite Modification Date:
2026-02-25 @ 9:45 PM
Study NCT ID:
NCT03923361
Status:
WITHDRAWN
Last Update Posted:
2019-12-18
First Post:
2019-04-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neural and Antidepressant Effects of Propofol (Phase 2)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D061218', 'term': 'Depressive Disorder, Treatment-Resistant'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Change in study design based on phase 1 data collection; patient burden was not feasible', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-13', 'studyFirstSubmitDate': '2019-04-19', 'studyFirstSubmitQcDate': '2019-04-19', 'lastUpdatePostDateStruct': {'date': '2019-12-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hamilton Rating Scale for Depression', 'timeFrame': '3 weeks after baseline', 'description': '24-item Hamilton Depression Rating Scale, total score Higher values represent more severe depressive symptoms Maximum score, 76; minimum score, 0 Remission defined as total score \\< 10 Response defined as decrease of total score from baseline \\> 50%'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Treatment Resistant Depression']}, 'descriptionModule': {'briefSummary': 'Moderate-intensity propofol treatments will be administered to participants who are non-responders at the end of Phase 1.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-55\n* Diagnosis of major depressive disorder or bipolar disorder\n* Current moderate-to-severe depressive episode\n* Episode duration more than 2 months and less than 5 years\n* Failure of at least 2 adequate antidepressant medication trials within the past 2 years\n* Body mass index \\< 40\n* 16-item Quick Inventory of Depressive Symptomatology, self-rated \\> 10\n\nExclusion Criteria:\n\n* Contraindication to propofol or midazolam\n* Daily use of benzodiazepine, opioid, ACE inhibitor, or ARB medication\n* Symptomatic coronary artery disease or heart failure\n* Poorly controlled hypertension or diabetes\n* Abnormal kidney or liver function\n* Pregnant or breast feeding\n* Traumatic brain injury or significant neurologic signs (past year)\n* Substance use disorder (past year)\n* Obsessive compulsive disorder (current)\n* Post-traumatic stress disorder (current)\n* Schizophrenia-spectrum disorder (lifetime)\n* Neurocognitive disorder (current)\n* Personality disorder as a current focus of treatment\n* ECT within the past 3 months\n* Inappropriate for ECT, or poor response to ECT within the past 5 years\n* Incompetent to provide consent'}, 'identificationModule': {'nctId': 'NCT03923361', 'briefTitle': 'Neural and Antidepressant Effects of Propofol (Phase 2)', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'Neural and Antidepressant Effects of Propofol (Phase 2)', 'orgStudyIdInfo': {'id': '00116093B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Propofol', 'interventionNames': ['Drug: Diprivan']}], 'interventions': [{'name': 'Diprivan', 'type': 'DRUG', 'otherNames': ['Propofol'], 'description': 'Similar to the high-intensity propofol treatments in Phase 1, the anesthesiologist will administer an induction dose of propofol followed by a continuous infusion, insert an airway, and begin mechanical ventilation. Propofol dosing will be adjusted with the goal of achieving a burst-suppression state with a SR of 40-60 for 12-15 minutes.', 'armGroupLabels': ['Propofol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84108', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Univeristy Neuropsychiatric Institute', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Brian Mickey', 'investigatorAffiliation': 'University of Utah'}}}}