Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2026-01-14 @ 11:44 PM
Study NCT ID:
NCT06597695
Status:
RECRUITING
Last Update Posted:
2025-07-28
First Post:
2024-09-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Ketamine-assisted Group Therapy Intervention for Spanish-speaking Adults With Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-23', 'studyFirstSubmitDate': '2024-09-12', 'studyFirstSubmitQcDate': '2024-09-12', 'lastUpdatePostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate feasibility of a culturally adapted group-based ketamine intervention for Spanish- speaking adults with depression in a community setting', 'timeFrame': '1 week post-intervention', 'description': '(a) Assess the attendance and adherence rates of participants to the group-based ketamine intervention sessions; (b) Evaluate the feasibility of delivering the intervention sessions as planned, including the preparatory, dosing, and integration sessions; (c) Explore the perceptions and experiences of Spanish-speaking participants regarding the intervention.'}, {'measure': 'To assess the safety of a ketamine-assisted group psychotherapy intervention for Spanish-speaking participants with depression in a community setting.', 'timeFrame': '1 week post-intervention', 'description': '(a) assess safety as obtained through vital monitoring; heart-rate variability (HRV) monitoring, EKG, as measured by a Fitbit. (b) evaluate physical and psychological adverse effects at each study visit.'}], 'secondaryOutcomes': [{'measure': 'Investigate the preliminary efficacy of the group-based ketamine intervention on psychiatric symptoms, wellbeing, and health behaviors among Spanish-speaking participants with depression.', 'timeFrame': '1 and 12 weeks post-intervention', 'description': '(a) Assess changes in psychiatric symptom scales pre- and post-intervention using validated assessment tools. (b) Measure changes in wellbeing (social wellbeing, personal wellbeing, spiritual health) pre- and post- intervention through self-report scales. Explore shifts in health behaviors pre-and post-intervention, through self-report and accelerometry measures.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Depression']}, 'descriptionModule': {'briefSummary': 'This is a pilot clinical trial to assess the feasibility, safety, and preliminary efficacy of ketamine-assisted group therapy for Spanish-speaking adults with depression'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Self-identifying Latinx, Spanish-speaking 2. Adults 18-64 years 3. Meet DSM-5 criteria for major depressive disorder as evaluated by study clinician 4. Montgomery-Asberg depression scale (MADRS) score of 20 or above at baseline 4. Participants must have an MGB psychiatrist and primary care provider.\n\nExclusion Criteria:\n\n1. History of primary psychotic disorder, by history\n2. History Bipolar I disorder, by history\n3. Unstable complex PTSD, as assessed by study clinician\n4. History of dissociative identity disorder\n5. History of neurocognitive disorder\n6. History of severe and/or recent substance use disorder, by history and as assessed by study clinician after clinical evaluation and interview\n7. Uncontrolled hypertension, tachycardia, or unstable cardiopulmonary disease, by history a. Blood pressure on initial screen must be \\<140/90 mmHg.\n8. History of aortic dissection\n9. History of myocardial infarction\n10. History of aneurysm\n11. History of hepatic impairment.\n12. History of epilepsy\n13. History of prior hypersensitivity to ketamine\n14. Body Mass Index greater than 35\n15. Body Mass Index less than 18.5\n16. Are pregnant, breastfeeding, or planning to become pregnant within 12 weeks of treatment completion\n17. Enrolled in other clinical trial for the treatment of depression or other behavioral health diagnosis\n18. Inability to provide consent.'}, 'identificationModule': {'nctId': 'NCT06597695', 'briefTitle': 'A Ketamine-assisted Group Therapy Intervention for Spanish-speaking Adults With Depression', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'A Ketamine-assisted Group Therapy Intervention for Spanish-speaking Adults With Depression', 'orgStudyIdInfo': {'id': '2024P002122'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Open label', 'description': 'Open label, single arm study', 'interventionNames': ['Drug: Ketamine-assisted psychotherapy']}], 'interventions': [{'name': 'Ketamine-assisted psychotherapy', 'type': 'DRUG', 'description': 'Ketamine-assisted psychotherapy delivered in a group format', 'armGroupLabels': ['Open label']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Chelsea', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Juliana zambrano, MD, MPH', 'role': 'CONTACT', 'email': 'jzambrano2@mgh.harvard.edu', 'phone': '6177262000'}], 'facility': 'Massachusetts General Hospital, Chelsea', 'geoPoint': {'lat': 42.39176, 'lon': -71.03283}}], 'centralContacts': [{'name': 'Juliana Zambrano, MD', 'role': 'CONTACT', 'email': 'JZAMBRANO2@mgh.harvard.edu', 'phone': '617-726-2000'}], 'overallOfficials': [{'name': 'Juliana Zambrano, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Juliana Zambrano, MD, MPH', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Psychiatrist', 'investigatorFullName': 'Juliana Zambrano, MD, MPH', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}