Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-01-04 @ 9:01 AM
Study NCT ID:
NCT03788694
Status:
WITHDRAWN
Last Update Posted:
2023-08-07
First Post:
2018-12-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intranasal Ketamine for Suicidal Ideation in Veterans
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': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study was never funded nor started, no participants were enrolled', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-03', 'studyFirstSubmitDate': '2018-12-26', 'studyFirstSubmitQcDate': '2018-12-26', 'lastUpdatePostDateStruct': {'date': '2023-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Beck Scale for Suicidal Ideation (BSSI)', 'timeFrame': 'Baseline Visit to End of Treatment Visit- approximately 3-4.5 weeks', 'description': "Beck Scale is a 21-item self or clinician administered instrumentation used to measure the current intensity of patients' specific attitudes, behaviors and plans to commit suicide. Score range 0-42, with higher score indicating higher intensity."}], 'secondaryOutcomes': [{'measure': 'Montgomery-Asberg Depression Rating Scale (MADRS)', 'timeFrame': 'Baseline Visit to End of Treatment Visit- approximately 3-4.5 weeks', 'description': 'The MADRS is a 10-item instrument used for the evaluation of depressive symptoms in adults and for the assessment of any changes to those symptoms. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.'}, {'measure': 'The Quick Inventory of Depressive Symptomatology, Self-Report (QIDS-SR)', 'timeFrame': 'Baseline Visit to End of Treatment Visit- approximately 3-4.5 weeks', 'description': 'QIDS-SR is a 16-item self-rated instrument designed to assess the severity of depressive symptoms present in the past seven days (Rush et al. 2003). The 16 items cover the nine symptom domains of major depression, and are rated on a scale of 0-3.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ketamine', 'Veteran', 'Suicide', 'Suicidal Ideation'], 'conditions': ['Suicidal Ideation']}, 'descriptionModule': {'briefSummary': 'The objective of the current study is to investigate the safety, efficacy, and feasibility of multiple doses of intranasal (IN) ketamine for suicidal ideation Veterans.', 'detailedDescription': 'To address the significant need for effective treatment of suicidal ideation in Veterans, this trial is designed as an open label pilot study of intranasal ketamine in 15 people.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or female patients, 21-70 years of age\n2. Female individuals who are not of childbearing potential (i.e., surgically sterile, postmenopausal for at least one year) or using a medically accepted reliable means of contraception. Women using oral contraceptive medication for birth control must also be using a barrier contraceptive. Women of childbearing potential must also have a negative pregnancy test at screening and at pre-administration\n3. Any non-psychotic disorder diagnosis\n4. Score \\>4 on the suicide item of the Montgomery-Asberg Depression Rating Scale (MADRS-SI; range 0-6)for clinically significant suicidal ideation or past suicide attempts\n5. Each participant must have a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign an informed consent document\n6. Each participant must agree to avoid future enrollment in ketamine trials.\n\nExclusion Criteria:\n\n1. current psychotic symptoms or lifetime history of primary psychotic disorder\n2. active substance use in the preceding two weeks or needing medical attention for withdrawal\n3. neurodevelopmental disorder (e.g., ASD)\n4. major neurocognitive disorder (e.g., Alzheimer's type dementia)\n5. serious cardiac disease\n6. suicide attempt precipitating current admission requiring medical stabilization\n7. Lifetime histories of autism, mental retardation, pervasive developmental disorders, or Tourette's syndrome\n8. Women who are either pregnant or nursing\n9. Hypertension (systolic BP \\>160 mm Hg or diastolic BP \\>90 mm Hg) at screening or immediately prior to treatment with study drug\n10. Previously received ketamine for refractory depression."}, 'identificationModule': {'nctId': 'NCT03788694', 'briefTitle': 'Intranasal Ketamine for Suicidal Ideation in Veterans', 'organization': {'class': 'OTHER', 'fullName': 'Bronx Veterans Medical Research Foundation, Inc'}, 'officialTitle': 'Pilot Study of Open Label, Intranasal Ketamine for Suicidal Ideation in Veterans', 'orgStudyIdInfo': {'id': 'GOO-17-048'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intranasal Ketamine', 'description': 'Subjects will receive study medication, intranasal ketamine.', 'interventionNames': ['Drug: Ketamine']}], 'interventions': [{'name': 'Ketamine', 'type': 'DRUG', 'description': '8 doses of intranasal ketamine; 40 mg per dose.', 'armGroupLabels': ['Intranasal Ketamine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10468', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'James J. Peters VA Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': '6 months after publication and will remain available for 5 years.', 'ipdSharing': 'YES', 'description': 'All IPD that underlie results in publications as well as study protocol, statistical analysis plan, informed consent form.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bronx Veterans Medical Research Foundation, Inc', 'class': 'OTHER'}, 'collaborators': [{'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Director, VISN 2 Mental Illness, Reseach, Education, Clinical Center (MIRECC) Director, Suicide Prevention and Treatment Research Program', 'investigatorFullName': 'Marianne Goodman', 'investigatorAffiliation': 'James J. Peters Veterans Affairs Medical Center'}}}}