Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2026-01-01 @ 3:00 PM
Study NCT ID:
NCT05026203
Status:
COMPLETED
Last Update Posted:
2024-03-15
First Post:
2021-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Ketamine Treatment for Three Consecutive Days in 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007649', 'term': 'Ketamine'}, {'id': 'D008874', 'term': 'Midazolam'}], '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': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-12', 'studyFirstSubmitDate': '2021-08-24', 'studyFirstSubmitQcDate': '2021-08-27', 'lastUpdatePostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Montgomery-Åsberg Depression Rating Scale (MADRS)', 'timeFrame': '1 month', 'description': 'decrease more than 50% of scale from baseline is defined as remission'}], 'secondaryOutcomes': [{'measure': 'dissociation', 'timeFrame': 'immediately after administraion', 'description': 'The dissociative experiences measure, Oxford (DEMO)'}, {'measure': 'health questionnaire', 'timeFrame': '1 month', 'description': 'The 5-level EQ-5D version (EQ-5D-5L)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Depression']}, 'referencesModule': {'references': [{'pmid': '39026266', 'type': 'DERIVED', 'citation': 'Pattanaseri K, Lortrakul J, Jaisin K, Srifuengfung M, Sa-Nguanpanich N, Viravan N, Pariwatcharakul P, Makarasara W, Ratta-Apha W. A randomized controlled pilot study of daily intravenous ketamine over three days for treatment-resistant depression. BMC Psychiatry. 2024 Jul 18;24(1):512. doi: 10.1186/s12888-024-05951-5.'}]}, 'descriptionModule': {'briefSummary': 'Inclusion criteria: 1. patient over 20 years old with depression diagnosed by a psychiatrist and MADRS \\>= 25 scores; 2. failed to improve by at least optimal dosage of two antidepressants for four weeks and one psychotherapy. Patients and outcome assessors will be blinded from intervention the patients have.\n\nParticipants will be randomized into two groups that are intervention (ketamine 0.5 mg/kg IV drip in 40 minutes) and control (midazolam 0.045 mg/kg IV drip in 40 minutes) groups. Participants will administer ketamine/midazolam once daily for three consecutive days. They will be evaluate MADRS changing, vital signs, dissociative symptoms, CGI, and quality of life (EQ-5D-5L) during the treatment, at 1 week and 4 weeks after treatment completion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* over 20 years old\n* depression was diagnosed by a psychiatrist and having MADRS \\>= 25\n* depression treated with 2 optimal dosage of antidepressants for 4 weeks and one psychotherapy\n* stable dosage of current medications for 4 weeks\n* fluently Thai\n\nExclusion Criteria:\n\n* secondary depression\n* PTSD\n* current pregnancy\n* history of increased intracranial hemorrhage, increased intracranial pressure, severe head injury, abnormal thyroid function, angina, heart failure, arrhythmia, aneurysm, uncontrolled hypertension, chronic lower tract respiratory disease, myasthenia gravis, glaucoma, dementia, acute porphyria, or cystitic (within 3 months prior to recruitment)\n* allergy to ketamine or midazolam\n* history of substance use disorder within 1 year prior to recruitment\n* history of psychosis within 3 months\n* history of bipolar disorder\n* BMI over 35\n* frail medical condition\n* currently ECT or TMS'}, 'identificationModule': {'nctId': 'NCT05026203', 'briefTitle': 'Effectiveness of Ketamine Treatment for Three Consecutive Days in Depression', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Effectiveness of Ketamine Treatment in Difficult-to-treat Depression Comparing With Midazolam: a Double-blind Randomized Controlled Trial and Its Cost Effectiveness Analysis', 'orgStudyIdInfo': {'id': '109/2564(IRB1)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ketamine', 'interventionNames': ['Drug: Ketamine Hydrochloride']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Midazolam', 'interventionNames': ['Drug: Midazolam']}], 'interventions': [{'name': 'Ketamine Hydrochloride', 'type': 'DRUG', 'description': 'Ketamine hydrochloride 0.5 mg/kg intravenous administer in 40 minutes per day for 3 consecutive days', 'armGroupLabels': ['Ketamine']}, {'name': 'Midazolam', 'type': 'DRUG', 'description': 'Midazolam', 'armGroupLabels': ['Midazolam']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Keerati Pattanaseri', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consualtant psychiatrist', 'investigatorFullName': 'Keerati Pattanaseri', 'investigatorAffiliation': 'Mahidol University'}}}}