Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2026-01-01 @ 12:09 AM
Study NCT ID:
NCT04021433
Status:
UNKNOWN
Last Update Posted:
2019-07-16
First Post:
2019-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ketamine for Treatment Resistant MDD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'open'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-15', 'studyFirstSubmitDate': '2019-07-10', 'studyFirstSubmitQcDate': '2019-07-15', 'lastUpdatePostDateStruct': {'date': '2019-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MADRS', 'timeFrame': '1 month into treatment through study completion', 'description': 'The change in the MDRS score at 1 month (5weeks evaluation) for the acute phase and at 6 months or end of study (for the maintenance phase) compared to baseline'}], 'secondaryOutcomes': [{'measure': 'MADRS', 'timeFrame': '3 months into treatment', 'description': 'The change in MADRS score at 3 months compared to baseline.'}, {'measure': 'QIDS-SR, Clinical Global Impressions - Improvement', 'timeFrame': 'along 6 months', 'description': 'The change in QIDS-SR and CGI scores at 1, 3 and 6 months compared to baseline.'}, {'measure': 'Average time in remission', 'timeFrame': 'along 6 months', 'description': 'Average time in remission.'}, {'measure': 'NeuroTrax computerized cognitive battery', 'timeFrame': 'along 6 months', 'description': 'Changes in cognitive function at 1 and 6 months \\[or at study end\\] as assessed by the NeuroTrax computerized cognitive battery compared to baseline.\n\ncorrelation between information processing speed and other cognitive domains at baseline and clinical outcomes.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Depressive Disorder, Major']}, 'descriptionModule': {'briefSummary': 'This study aims to openly test the long-term safety, tolerability and effectiveness of repeated administration of IM/SC ketamine for treatment resistant MDD.', 'detailedDescription': "Major depression disorder (MDD) is a common psychiatric disorders with considerable impact on patients' quality of life, social and occupational function. MDD also significantly increase suicide rate. About a third of the patients with MDD suffer from moderate to severe symptoms that are fully or partially unresponsive to accepted pharmaco and / or psycho therapy. Ketamine is a widely used anesthetic. Multiple studies done over the recent years had shown its therapeutic effects in resistant depressive patients. Unlike regular antidepressants, ketamine exerts its effect within hours to few days which implies an alternative mechanism of action not fully studied. So far, there are only few reports on using repeated ketamine administration to maintain the antidepressant effect or on intra-muscular or sub-cutaneous application that can be safer and more tolerable than the intravenous route.\n\nIn the present study, the investigators aim to openly assess the safety, tolerability and effectiveness of repeated, individually tailored IM or SC ketamine for treatment resistant major depression. The investigators intend to explore questions regarding optimal dose, treatment frequency and duration. The investigators will also assess potential cognitive effects of long-term ketamine treatment and look for possible treatment outcome predictors using the Neurotrax computerized cognitive battery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with unipolar/bipolar depression with MADRS Score\\>= 20\n* Inadequate response to \\>= 3 adequate treatment trials \\[\\>=2 trials in the present episode\\]\n* If on psychopharmacological Tx, it should be stable since 4 weeks prior to enrollment\n* QTc WNL\n\nExclusion Criteria:\n\n* Hypersensitivity to ketamine\n* Other major psychiatric diagnosis\n* High suicidality\n* Unstable physical illness\n* S/P CVA / brain SOL\n* Pregnant or breast feeding women\n* Illicit drug/alcohol abuse during last year\n* History of ketamine abuse'}, 'identificationModule': {'nctId': 'NCT04021433', 'briefTitle': 'Ketamine for Treatment Resistant MDD', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'officialTitle': 'Ketamine for Treatment Resistant Depression - A Long Term Feasibility Study', 'orgStudyIdInfo': {'id': '58717-HMO-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MDD', 'description': 'Treatment resistant patients will be treated with multiple doses of IM/SC ketamine \\[dose range 0.3-1.5mg/kg\\]', 'interventionNames': ['Drug: Ketamine']}], 'interventions': [{'name': 'Ketamine', 'type': 'DRUG', 'description': 'Repeated doses of IM/SC ketamine up to 3 times a week', 'armGroupLabels': ['MDD']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jerusalem', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Isserles Moshe, MD, MSc', 'role': 'CONTACT'}], 'facility': 'Hadassah Hebrew University Medical Center', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'centralContacts': [{'name': 'Moshe Isserles, MD', 'role': 'CONTACT', 'email': 'moshay@hadassah.org.il', 'phone': '00972 2 6777184'}, {'name': 'Hadas Lamberg, PhD', 'role': 'CONTACT', 'email': 'lhadas@hadassah.org.il', 'phone': '00 972 2 6777572'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}