Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:27 PM
Study NCT ID:
NCT06164756
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-07-11
First Post:
2023-12-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Long Term Follow Up KET-PD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-10-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-12-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-09', 'studyFirstSubmitDate': '2023-12-01', 'studyFirstSubmitQcDate': '2023-12-01', 'lastUpdatePostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Long-Term Change in Depression Severity', 'timeFrame': '3 Months and 6 Months', 'description': 'Change in MADRS score following course of ketamine vs. placebo treatment at 3 and 6 month timepoints; and change in MADRS across treatment (ketamine/placebo) and follow-up (CBT/TAU) arms at 3 and 6 month timepoints. The scale used to measure depression severity is called The Montgomery-Åsberg Depression Rating Scale (MADRS). The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. The overall score ranges from 0 to 60, higher MADRS score indicates more severe depression.'}], 'secondaryOutcomes': [{'measure': 'Change in Apathy', 'timeFrame': '3 Months and 6 Months', 'description': 'Changes in apathy determined by the Starkstein Apathy Scale (SAS) scale'}, {'measure': 'Change in Anxiety', 'timeFrame': '3 Months and 6 Months', 'description': 'Changes in anxiety determined by the State-Trait Anxiety Inventory (STAI) scale'}, {'measure': "Change in Parkinson's Symptom Severity", 'timeFrame': '3 Months and 6 Months', 'description': "Changes in Parkinson's symptom severity determined by the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) scale"}, {'measure': 'Change in Dyskinesia', 'timeFrame': '3 Months and 6 Months', 'description': 'Changes in dyskinesia determined by the Unified Dyskinesia Rating Scale (UDysRS) scale'}, {'measure': 'Change in Pain', 'timeFrame': '3 Months and 6 Months', 'description': "Changes in pain determined by the King's PD Pain Scale"}, {'measure': 'Change in Fatigue', 'timeFrame': '3 Months and 6 Months', 'description': "Changes in fatigue determined by the Parkinson's Fatigue Scale (PFS)"}, {'measure': 'Change in Anhedonia', 'timeFrame': '3 Months and 6 Months', 'description': 'Changes in anhedonia determined by the Snaith-Hamilton Pleasure Scale (SHAPS)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Long Term Effect Ketamine Treatment'], 'conditions': ["Parkinson's Disease", 'Depression']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to examine a) the longer-term effects of ketamine for treating depression in Parkinson's disease (PD) and b) the effects of CBT on maintaining the effects of ketamine.", 'detailedDescription': 'This is a roll-out study from the ongoing clinical trial (KET-PD trial; NCT04944017, HIC 2000030394). We will adopt an implementation science approach to have participants across ketamine and placebo groups in one of two arms: a) follow-up with treatment as usual (TAU) (at 3 and 6 months post-infusions); b) follow-up with 3 months of Cognitive Behavior Therapy (CBT) post-infusions, delivered remotely once per week, with follow-up assessments at 3 and 6 month timepoints. CBT is expected to have a superior sustained antidepressant response to the TAU follow-up group in both ketamine and placebo arms. We hypothesize that ketamine + CBT will show the most superior antidepressant response at follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A total of n=56 participants with PD and comorbid depression, age 40-80, are being recruited under the parent clinical trial. As of July 2023, 20 participants have been enrolled. We aim to follow-up our remaining participants longitudinally and, within this, to have 20 prospective participants receive CBT, such that we will have 20 participants in each follow-up arm (CBT vs. TAU), and ultimately 10 in each group (ketamine + CBT, ketamine + TAU, placebo + CBT, placebo + TAU).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Eligibility is determined in the ongoing parent clinical trial (KET-PD trial; NCT04944017, HIC 2000030394).'}, 'identificationModule': {'nctId': 'NCT06164756', 'briefTitle': 'Long Term Follow Up KET-PD', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': "Long-Term Follow-Up for Subjects Enrolled in the Ketamine for the Treatment of Depression in Parkinson's Disease (KET-PD) Trial", 'orgStudyIdInfo': {'id': '2000036071'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Experimental: Ketamine Infusion', 'description': 'Participants who received 6 infusions of ketamine (0.5 mg/kg IV, up to 60 mg total), administered over 40 minutes while on continuous cardiac monitoring and oximetry in the ongoing clinical trial (KET-PD trial; NCT04944017, HIC 2000030394)', 'interventionNames': ['Other: Cognitive Behavior Therapy (CBT)', 'Other: Treatment As Usual (TAU)']}, {'label': 'Placebo Comparator: Saline Infusion', 'description': 'Participants who received 6 infusions of placebo (saline IV), administered over 40 minutes while on continuous cardiac monitoring and oximetry in the ongoing clinical trial (KET-PD trial; NCT04944017, HIC 2000030394)', 'interventionNames': ['Other: Cognitive Behavior Therapy (CBT)', 'Other: Treatment As Usual (TAU)']}], 'interventions': [{'name': 'Cognitive Behavior Therapy (CBT)', 'type': 'OTHER', 'description': 'Participants will receive 10 weeks of CBT', 'armGroupLabels': ['Experimental: Ketamine Infusion', 'Placebo Comparator: Saline Infusion']}, {'name': 'Treatment As Usual (TAU)', 'type': 'OTHER', 'description': 'Participants will receive standard of care treatment', 'armGroupLabels': ['Experimental: Ketamine Infusion', 'Placebo Comparator: Saline Infusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale New Haven Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Sophie E. Holmes, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': "Fox (Michael J.) Foundation for Parkinson's Research", 'class': 'UNKNOWN'}, {'name': 'Yale School of Medicine Center for Brain Mind Health', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Psychiatry', 'investigatorFullName': 'Sophie Holmes', 'investigatorAffiliation': 'Yale University'}}}}