Ignite Creation Date:
2025-12-24 @ 1:42 PM
Ignite Modification Date:
2025-12-27 @ 9:08 PM
Study NCT ID:
NCT01892995
Status:
UNKNOWN
Last Update Posted:
2015-02-16
First Post:
2013-07-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ketamine for Acute Suicidal Ideation in the Emergency Department: Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013405', 'term': 'Suicide'}, {'id': 'D059020', 'term': 'Suicidal Ideation'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 53}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'lastUpdateSubmitDate': '2015-02-13', 'studyFirstSubmitDate': '2013-07-02', 'studyFirstSubmitQcDate': '2013-07-02', 'lastUpdatePostDateStruct': {'date': '2015-02-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Beck Scale for Suicidal Ideation', 'timeFrame': '2 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['suicide', 'ketamine', 'low-dose ketamine', 'suicidal ideations', 'emergency department'], 'conditions': ['Suicide']}, 'descriptionModule': {'briefSummary': 'This study will enroll patients presenting to the emergency department with acute suicidal ideation meeting inclusion and exclusion criteria. Patients will be randomized to one of three arms: ketamine (intervention) or diphenhydramine (control) or placebo (control). Serial measurements will be made in the ED and at follow-up intervals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients age 18 to less than 75 who present to the SAMMC ED with either overt or incidental suicidal ideations with a SADPERSONS score 5 or greater that the treating provider feels warrant formal evaluation.\n\nExclusion Criteria:\n\n* -Poor vital sign stability hypoxia: O2 \\< 95%, hypotension: SBP\\< 90 hypertension: SBP\\>180 Heart rate: \\< 50 or \\>120 Respiratory Rate: \\<10 or \\>30\n* Altered mental status or intoxication\n* Patient is unwilling to participate or provide informed consent\n* Any allergy to ketamine or diphenhydramine\n* Patient is female of child-bearing age and unwilling to provide urine or blood for HCG analysis\n* Pregnancy or breast feeding\n* Presence of chronic oxygen-dependent pulmonary disease, liver cirrhosis, or renal disease requiring dialysis\n* Presence of ischemic heart disease, heart failure, or a history of unstable dysrhythmias\n* Presence of intracranial mass or vascular lesion.\n* Presence of a history of psychosis or hallucinations (as assessed by electronic chart review)\n* Weight greater than 115 kg or less than 45kg\n* History of increased intracranial pressure/hypertensive hydrocephalus\n* Non-English speaking patients\n* Patient is acutely psychotic\n* Provider feels that patient currently or likely will require chemical and/or physical restraints\n* History of prolonged QT-interval'}, 'identificationModule': {'nctId': 'NCT01892995', 'acronym': 'LDK-SI', 'briefTitle': 'Ketamine for Acute Suicidal Ideation in the Emergency Department: Randomized Controlled Trial', 'nctIdAliases': ['NCT02367586'], 'organization': {'class': 'FED', 'fullName': 'Brooke Army Medical Center'}, 'officialTitle': 'Ketamine for Acute Suicidal Ideation in the Emergency Department: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'BAMC-385833-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ketamine', 'description': 'active arm', 'interventionNames': ['Drug: Ketamine']}, {'type': 'SHAM_COMPARATOR', 'label': 'Diphenhydramine', 'description': 'sham arm', 'interventionNames': ['Drug: Ketamine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline', 'description': 'placebo', 'interventionNames': ['Drug: Ketamine']}], 'interventions': [{'name': 'Ketamine', 'type': 'DRUG', 'armGroupLabels': ['Diphenhydramine', 'Ketamine', 'Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78234', 'city': 'Fort Sam Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Brooke Army Medical Center', 'geoPoint': {'lat': 29.45303, 'lon': -98.4417}}], 'centralContacts': [{'name': 'Steven G Schauer, DO', 'role': 'CONTACT', 'email': 'sgschauer@gmail.com', 'phone': '2109160808'}, {'name': 'Shawn M Varney, DO', 'role': 'CONTACT', 'email': 'shawn.m.varney.mil@mail.mil', 'phone': '2109160808'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brooke Army Medical Center', 'class': 'FED'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'CPT', 'investigatorFullName': 'Steven Schauer', 'investigatorAffiliation': 'Brooke Army Medical Center'}}}}