Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2025-12-25 @ 8:39 PM
Study NCT ID:
NCT06736769
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-06-10
First Post:
2024-12-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ketamine Effects on Learning In Eating Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000856', 'term': 'Anorexia Nervosa'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D000855', 'term': 'Anorexia'}, {'id': 'D001068', 'term': 'Feeding and Eating Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-05', 'studyFirstSubmitDate': '2024-12-12', 'studyFirstSubmitQcDate': '2024-12-12', 'lastUpdatePostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change From Baseline in Reversal Learning', 'timeFrame': 'Day 2, Day 4', 'description': 'Mean change in reversal learning as measured by the probabilistic reversal learning task.In the task, participants are presented with two stimuli, told to choose one of the two stimuli on each trial, and receive feedback regarding whether the stimulus is "Correct" or "Incorrect." Participants must modify their choice based on c hanging stimulus-outcome contingencies over time, engaging flexible learning.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anxiety', 'Depression', 'Anorexia', 'Psychotropic Drugs', 'Feeding and Eating Disorders', 'Physiological Effects of Drugs', 'Cognitive Flexibility'], 'conditions': ['Anorexia Nervosa', 'Atypical Anorexia Nervosa']}, 'descriptionModule': {'briefSummary': 'This is a single site, single dose clinical trial of intravenous (IV) ketamine for medically hospitalized adolescents and young adults with anorexia nervosa or atypical anorexia nervosa. Eating disorder symptoms will be measured pre- and post-ketamine infusion. Investigators hypothesize that ketamine will increase cognitive flexibility, making medical hospitalizations less distressing by improving the ability to learn new, positive associations with food.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '26 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 16-26 years old\n2. Meets diagnosis of anorexia nervosa (AN) or atypical anorexia nervosa (atypical AN) per DSM-5 criteria on admission\n3. Admitted to the medical hospital for malnutrition\n4. No changes to psychiatric medications for month prior to trial enrollment\n5. Agree to use a highly effective form of contraception for at least two weeks following ketamine administration\n6. Have an outpatient primary care provider, medical provider, or behavioral health provider or psychiatrist who is actively managing or coordinating care\n\nExclusion Criteria:\n\n1. Lifetime history of any psychotic disorder\n2. Moderate or severe substance use disorder\n3. Pregnancy as indicated by a positive urine pregnancy test during screening, lactation, or the intention of becoming pregnant within 3 months of entry into this trial\n4. Electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) treatment within 30 days prior to enrollment\n5. Intellectual or developmental disability\n6. High risk for self-harm/suicide\n7. Active laxative misuse or abuse\n8. Biochemical refeeding syndrome or electrolyte abnormality\n9. Cardiac abnormalities identified on admission\n10. Taking medications that would be unsafe to administer with ketamine\n11. Other medical condition or diagnosis, physical exam finding, laboratory abnormality, or health risk that would increase the risk of adverse events, at the discretion of the investigators'}, 'identificationModule': {'nctId': 'NCT06736769', 'acronym': 'KETTLE', 'briefTitle': 'Ketamine Effects on Learning In Eating Disorders', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': '"KETTLE" Trial: Ketamine Effects on Learning In Eating Disorders', 'orgStudyIdInfo': {'id': 'KL2TR001870', 'link': 'https://reporter.nih.gov/quickSearch/KL2TR001870', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'KL2TR001870', 'link': 'https://reporter.nih.gov/quickSearch/KL2TR001870', 'type': 'NIH'}, {'id': 'P0541014', 'type': 'OTHER', 'domain': 'UCSF Clinical and Translational Science Institute (CTSI) Proposal Number'}, {'id': '24--42123', 'type': 'OTHER', 'domain': 'UCSF Institutional Review Board Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ketamine Infusion', 'interventionNames': ['Drug: Ketamine infusion']}], 'interventions': [{'name': 'Ketamine infusion', 'type': 'DRUG', 'description': 'Ketamine will be delivered intravenously at 0.5 mg/kg over 40 minutes.', 'armGroupLabels': ['Ketamine Infusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Amanda E. Downey, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amanda Downey, MD', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Advancing Translational Sciences (NCATS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Pediatrics and Psychiatry and Behavioral Sciences', 'investigatorFullName': 'Amanda Downey, MD', 'investigatorAffiliation': 'University of California, San Francisco'}}}}