Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-01-11 @ 1:17 PM
Study NCT ID:
NCT01613820
Status:
WITHDRAWN
Last Update Posted:
2018-02-19
First Post:
2012-05-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ketamine and Scopolamine Infusions for Treatment-resistant Major Depressive Disorder
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'}, {'id': 'D012601', 'term': 'Scopolamine'}], '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'}, {'id': 'D012602', 'term': 'Scopolamine Derivatives'}, {'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D001533', 'term': 'Belladonna Alkaloids'}, {'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}]}}, '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'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Lack of funding', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-15', 'studyFirstSubmitDate': '2012-05-31', 'studyFirstSubmitQcDate': '2012-06-05', 'lastUpdatePostDateStruct': {'date': '2018-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hamilton Depression Rating Scale - 28 items', 'timeFrame': 'up to 4 months', 'description': 'Subjects will be assessed with HAMD-28'}], 'secondaryOutcomes': [{'measure': 'Systematic Assessment for Treatment Emergent Events (SAFTEE)', 'timeFrame': 'up to 4 months', 'description': 'Subjects will be monitored for emergence of side effects weekly for the first 8 weeks, then every two weeks for 8 weeks.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Major Depressive Disorder']}, 'descriptionModule': {'briefSummary': 'Ketamine infusions resulted in an acute reduction in global depression scores and in severity of suicidal ideation. Scopolamine infusions produced also a significant improvement in depression that was sustained over time.\n\nWe therefore plan to investigate the feasibility and efficacy of open-label repeated intravenous administration of ketamine and scopolamine combined in this population of severely depressed, treatment-resistant patients. The results from this study could lead to the development of new strategies for the treatment of patients with TRD.', 'detailedDescription': 'Patients will undergo two weeks of prospective observation, they will then receive IV infusions of ketamine, scopolamine or both per randomization as augmentation of their ongoing antidepressant regime. The schedule of administration will be twice a week of three weeks. After this phase the subject will be followed with assessments every two weeks for three months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Outpatients with sever treatment-resistant depression\n* Currently depressed\n* Currently under regular psychiatric care\n* On an aggressive antidepressant regimen, stable for 4 weeks\n\nExclusion Criteria:\n\n* No history of other major psychiatric illnesses, including bipolar disorder\n* No history of psychosis\n* No history of drug abuse\n* No major medical illness or unstable medical condition.'}, 'identificationModule': {'nctId': 'NCT01613820', 'briefTitle': 'Ketamine and Scopolamine Infusions for Treatment-resistant Major Depressive Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Combination of Anticholinergic and Glutamatergic Effects in Treatment-resistant Major Depressive Disorder. A Pilot Study', 'orgStudyIdInfo': {'id': '2012-P-000624'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ketamine plus placebo', 'description': 'Subjects assigned to this paradigm will receive a 15 minute infusion of normal saline (placebo) followed by IV ketamine at 0.25mg/kg over 45 minutes twice a week for 3 weeks.', 'interventionNames': ['Drug: Ketamine']}, {'type': 'EXPERIMENTAL', 'label': 'Scopolamine plus placebo', 'description': 'Subjects will receive a 15 minute infusion of IV scopolamine 2ug/kg followed by a 45 minute infusion of normal saline (placebo).', 'interventionNames': ['Drug: Scopolamine']}, {'type': 'EXPERIMENTAL', 'label': 'Ketamine plus scopolamine', 'description': 'Subject will receive an IV scopolamine infusion at a dose of 2ug/kg over 15 minutes, followed by an IV infusion of ketamine at a dose of 0.25mg/kg over 45 minutes.', 'interventionNames': ['Drug: Ketamine', 'Drug: Scopolamine']}], 'interventions': [{'name': 'Ketamine', 'type': 'DRUG', 'description': 'ketamine IV 0.25mg/kg infusions twice a week for 3 weeks as augmentation of ongoing antidepressant regimen.', 'armGroupLabels': ['Ketamine plus placebo', 'Ketamine plus scopolamine']}, {'name': 'Scopolamine', 'type': 'DRUG', 'description': 'Scopolamine 2ug/kg over 15 minutes twice a week for 3 weeks as augmentation of ongoing antidepressant regimen', 'armGroupLabels': ['Ketamine plus scopolamine', 'Scopolamine plus placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Depression Clinical and Reseach Program - MGH', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Cristina Cusin, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MGH Department of Psychiatry'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Instructor HMS', 'investigatorFullName': 'Cristina Cusin, MD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}