Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2026-03-01 @ 1:48 PM
Study NCT ID:
NCT05431595
Status:
RECRUITING
Last Update Posted:
2025-11-18
First Post:
2022-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Managing Agitated Delirium With Neuroleptics and Anti-Epileptics as a Neuroleptic Sparing Strategy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003693', 'term': 'Delirium'}, {'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006220', 'term': 'Haloperidol'}, {'id': 'D002746', 'term': 'Chlorpromazine'}, {'id': 'D014635', 'term': 'Valproic Acid'}], 'ancestors': [{'id': 'D002090', 'term': 'Butyrophenones'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010640', 'term': 'Phenothiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010421', 'term': 'Pentanoic Acids'}, {'id': 'D014631', 'term': 'Valerates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D005232', 'term': 'Fatty Acids, Volatile'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-02-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2022-06-20', 'studyFirstSubmitQcDate': '2022-06-20', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Edmonton Symptom Assessment Scale Questionnaire', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Edmonton Symptom Assessment Scale (ESAS)-score scale ranges from (0-10) No pain-0/Worse Possible Pain 10 (0-10)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Delirium', 'Epileptics', 'Neuroleptics']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'MD Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'To examine the effects of haloperidol, chlorpromazine, valproic acid and placebo, in conjunction with standardized non-pharmacologic interventions, in the first line treatment of agitated delirium in hospitalized patients with cancer. This double-blind, randomized clinical trial aims to provide evidence on various therapeutic options for palliating delirium, thereby reducing delirium-related distress and ultimately alleviating suffering.', 'detailedDescription': 'Objectives:\n\nPrimary objective:\n\nCompare the effect of scheduled haloperidol, chlorpromazine, valproate and placebo (non-pharmacological interventions alone) on the frequency of breakthrough restlessness over 72 hours in patients with agitated delirium seen by the palliative care consultation team. Our working hypothesis is that haloperidol, chlorpromazine, and valproate will lead to fewer episodes of breakthrough restlessness than placebo.\n\nSecondary Objective #1:\n\nCompare the effects of scheduled haloperidol, chlorpromazine, valproate and placebo on (1) RASS-PAL, (2) need for dose escalation, (3) perceived comfort by caregivers and bedside nurses, (4) delirium severity (Memorial Delirium Assessment Scale), (5) delirium-related distress in caregivers and nurses (Delirium Experience Questionnaire), (6) delirium recall in patients (Delirium Recall Questionnaire), (7) symptom expression (Edmonton Symptom Assessment Scale), (8) adverse effects, and (9) survival. Our working hypothesis is that haloperidol, chlorpromazine, and valproate are superior to placebo (non-pharmacologic interventions alone) in improving delirium-related outcomes.\n\nSecondary Objective #2:\n\nEstimate the efficacy of non-pharmacologic interventions alone on breakthrough restlessness. Our working hypothesis is that patients in the placebo group will require fewer breakthrough doses in the 72 hours after implementation of non-pharmacological interventions'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. \\[Patients\\] Diagnosis of advanced cancer (defined as locally advanced, metastatic recurrent, or incurable disease)\n2. \\[Patients\\] Seen by palliative care inpatient consultation team\n3. \\[Patients\\] Delirium as per DSM-5 criteria\n4. \\[Patients\\] Hyperactive or mixed delirium with either a rescue medication order or any non-pharmacologic measures (e.g. sitter, restraints) for agitation, restlessness, or delirium\n5. \\[Patients\\] Age 18 years or older\n6. \\[Patients\\] Permission from clinician from primary team to enroll\n7. \\[Family Caregivers\\] Patient's spouse, adult child, sibling, parent, other relative, or significant other (defined by the patient as a partner)\n8. \\[Family Caregivers\\] Age 18 years or older\n\nExclusion Criteria:\n\n1. \\[Patients\\] On scheduled haloperidol \\>4 mg/d, chlorpromazine \\>100 mg/d, or valproate \\>750 mg/d\n2. \\[Patients\\] History of myasthenia gravis, acute narrow-angle glaucoma, or hepatic encephalopathy as documented in chart\n3. \\[Patients\\] Hepatic dysfunction (unresolved AST or ALT \\>2.5x ULN, bilirubin \\>1.5x ULN or INR \\>1.5 within past month)\n4. \\[Patients\\] History of neuroleptic malignant syndrome as documented in chart\n5. \\[Patients\\] Active seizure disorder within past month as documented in chart\n6. \\[Patients\\] History of Parkinson's disease or dementia as documented in chart\n7. \\[Patients\\] History of prolonged QTc interval (\\>500 ms) if documented by most recent ECG within the past month\n8. \\[Patients\\] Hypersensitivity to haloperidol, chlorpromazine, or valproate as documented in chart\n9. \\[Patients\\] Pancreatitis within past month as documented in chart\n10. \\[Patients\\] Currently on lamotrigine, phenobarbital, or carbamazepine\n11. \\[Patients\\] Physical signs of impending death such as respiration with mandibular movement and death rattle\n12. \\[Patients\\] Pregnancy as documented in chart\n13. \\[Patients\\] Active COVID-19 infection as documented in chart"}, 'identificationModule': {'nctId': 'NCT05431595', 'briefTitle': 'Managing Agitated Delirium With Neuroleptics and Anti-Epileptics as a Neuroleptic Sparing Strategy', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Managing Agitated Delirium With Neuroleptics and Anti-Epileptics as a Neuroleptic Sparing Strategy', 'orgStudyIdInfo': {'id': '2022-0172'}, 'secondaryIdInfos': [{'id': 'NCI-2022-05252', 'type': 'OTHER', 'domain': 'NCI-CTRP Clinical Trial Reporting Registry'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'Participants will receive haloperidol by vein every 12 hours (or more often, as needed).', 'interventionNames': ['Drug: Haloperidol']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'Participants will receive chlorpromazine by vein every 12 hours (or more often, as needed).', 'interventionNames': ['Drug: Chlorpromazine']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3', 'description': 'Participants will receive valproate by vein every 12 hours.', 'interventionNames': ['Drug: Valproate']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4', 'description': 'Participants will receive placebo every by vein every 12 hours.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Haloperidol', 'type': 'DRUG', 'description': 'Given by Vein (IV)', 'armGroupLabels': ['Group 1']}, {'name': 'Chlorpromazine', 'type': 'DRUG', 'otherNames': ['Chlorpromazine hydrochloride, Thorazine®'], 'description': 'Given by Vein (IV)', 'armGroupLabels': ['Group 2']}, {'name': 'Valproate', 'type': 'DRUG', 'otherNames': ['Depakene', 'Valproate Acid'], 'description': 'Given by Vein (IV)', 'armGroupLabels': ['Group 3']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Given by Vein (IV)', 'armGroupLabels': ['Group 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'David Hui, MD', 'role': 'CONTACT', 'email': 'dhui@mdanderson.org', 'phone': '713-792-6258'}, {'name': 'David Hui, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'David Hui, MD', 'role': 'CONTACT', 'email': 'dhui@mdanderson.org', 'phone': '(713) 792-6258'}], 'overallOfficials': [{'name': 'David Hui, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cancer Prevention Research Institute of Texas', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}