Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2025-12-27 @ 9:23 PM
Study NCT ID:
NCT05105061
Status:
WITHDRAWN
Last Update Posted:
2022-04-05
First Post:
2021-10-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intramuscular Ketamine for Suicidal Ideation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059020', 'term': 'Suicidal Ideation'}, {'id': 'D013405', 'term': 'Suicide'}], 'ancestors': [{'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, '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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'PI leaving institution', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-03-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-24', 'studyFirstSubmitDate': '2021-10-22', 'studyFirstSubmitQcDate': '2021-10-22', 'lastUpdatePostDateStruct': {'date': '2022-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Auditory Mismatch Negativity (EEG)', 'timeFrame': 'Baseline and One hour post injection', 'description': 'Change in Mismatch Negativity (MMN) amplitude or latency from baseline up to one hour after injection.'}], 'secondaryOutcomes': [{'measure': 'Change in Montgomery-Asberg Depression Rating Scale (MADRS) #10 (SI)', 'timeFrame': 'Baseline and 24 hours post injection', 'description': 'Change in MADRS #10 from baseline to 24 hours post-injection. Score range from 0-5, with higher score indicating higher severity of symptoms.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Suicide', 'EEG', 'Ketamine'], 'conditions': ['Suicidal Ideation']}, 'descriptionModule': {'briefSummary': 'The objective of the present research protocol, a cross-over, subject-blinded, clinical trial, is to correlate changes in brain activity with reduction in suicidal ideation in response to a single intramuscular dose of ketamine. While ketamine is increasingly used as a rapid, antidepressant agent, there is accumulating evidence of additional anti-suicidal properties that may be distinct from its effects on depression. This pilot study will be used to determine (1) whether specific electroencephalogram (EEG) findings are correlated with response of SI to intramuscular (IM) ketamine, and (2) the effectiveness of IM ketamine in the treatment of acute SI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Current clinically significant suicidal ideation, defined as a score of \\> or = 4 on the MADRS item 10 and a positive answer on items 3,4 or 5 of the C-SSRS.\n* Inpatient status at the time of study initiation.\n* 18 to 70 years of age\n* Capacity to consent\n\nExclusion criteria:\n\n* Diagnosis of a primary psychotic disorder (e.g., schizoaffective disorder)\n* Diagnosis of pervasive developmental disorder\n* Diagnosis of a major neurocognitive disorder\n* A positive urine pregnancy test\n* Currently breastfeeding\n* Drug or alcohol abuse or dependence within the preceding 3 months; a rather narrow time period was chosen, however, in order to allow participation by individuals with a history of substance abuse or dependence problems that could be secondary to their SI, and to more closely approximate patients seen in real-world settings. Given the increasingly widespread use of marijuana, and in an effort to recruit a naturalistic study population, concurrent marijuana use is not an exclusion criterion, as long as they are not actively intoxicated.\n* Current positive UTOX for amphetamine, benzodiazepines, cocaine, opiates (if not prescribed)\n* Medical issues or laboratory abnormalities requiring acute intervention\n* Patients for whom an increase in blood pressure or intracranial pressure would pose a serious risk (e.g., aneurysmal vascular disease, arteriovenous malformation, history of intracerebral hemorrhage, unstable angina)\n* Any lifetime history of ketamine or phencyclidine abuse\n* A known hypersensitivity to or history of a serious adverse effect from to ketamine'}, 'identificationModule': {'nctId': 'NCT05105061', 'briefTitle': 'Intramuscular Ketamine for Suicidal Ideation', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'Intramuscular Ketamine Administration for the Treatment of Acute Suicidal Ideation With Concurrent EEG Monitoring', 'orgStudyIdInfo': {'id': 'STUDY-20-01496'}, 'secondaryIdInfos': [{'id': '21-1174', 'type': 'OTHER', 'domain': 'American Foundation for Suicide Prevention'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ketamine (1) then Placebo (2)', 'description': 'Participants will receive an intramuscular injection of racemic ketamine, followed the next day by an intramuscular injection of saline (placebo)', 'interventionNames': ['Drug: Ketamine (Ketalar)', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (1) then Ketamine (2)', 'description': 'Participants will receive an intramuscular injection of saline (placebo), followed the next day by an intramuscular injection of racemic ketamine', 'interventionNames': ['Drug: Ketamine (Ketalar)', 'Drug: Placebo']}], 'interventions': [{'name': 'Ketamine (Ketalar)', 'type': 'DRUG', 'description': '0.5 mg/kg of body weight', 'armGroupLabels': ['Ketamine (1) then Placebo (2)', 'Placebo (1) then Ketamine (2)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'IM injection of matching placebo', 'armGroupLabels': ['Ketamine (1) then Placebo (2)', 'Placebo (1) then Ketamine (2)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Matthew Klein', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Beginning 3 months and ending 5 years following article publication.', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).', 'accessCriteria': "Researchers who provide a methodologically sound proposal. Any purpose. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data will be made available the completion of the study."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Matthew Klein', 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}}