Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-27 @ 10:58 PM
Study NCT ID:
NCT01939093
Status:
COMPLETED
Last Update Posted:
2013-09-11
First Post:
2013-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Therapeutic Effect of Quetiapine on Methamphetamine-Induced Psychosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011618', 'term': 'Psychotic Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003975', 'term': 'Diazepam'}, {'id': 'D002936', 'term': 'Cinnarizine'}], 'ancestors': [{'id': 'D001570', 'term': 'Benzodiazepinones'}, {'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'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-05', 'studyFirstSubmitDate': '2013-09-02', 'studyFirstSubmitQcDate': '2013-09-05', 'lastUpdatePostDateStruct': {'date': '2013-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Positive and Negative Syndrome Scale', 'timeFrame': 'Every day in Week 1.'}, {'measure': 'Positive and Negative Syndrome Scale', 'timeFrame': 'Every two days in Week 2 and 3.'}], 'secondaryOutcomes': [{'measure': 'Antipsychotic Adverse Event Form', 'timeFrame': 'Every day for three weeks.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Quetiapine', 'Haloperidol', 'Methamphetamine', 'Psychosis'], 'conditions': ['Methamphetamine-induced Psychosis']}, 'descriptionModule': {'briefSummary': 'The aims of this study are to compare the antipsychotic and adverse events of quetiapine, an atypical antipsychotic drug, to haloperidol, a standard treatment for primary psychotic disorder, in individuals with MAP.', 'detailedDescription': 'Eighty individuals with MAP will be randomly assigned into two treatment groups, i.e. treatment with quetiapine and haloperidol. The quetiapine group will receive quetiapine at least 100 mg per day and the haloperidol group will receive haloperidol at least 2 mg per day orally once a day for four weeks. The doses will be increased every 5 days until no psychotic symptom is observed from the Positive and Negative Syndrome Scale. Common antipsychotic adverse events will be checked and documented daily.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having a psychotic episode with current use of methamphetamine\n* Positive urine toxicology test for methamphetamine on the first day of hospitalization\n\nExclusion Criteria:\n\n* Using other illegal substances\n* Having a history of primary psychotic disorders or using antipsychotic agents\n* Having a chronic medical disease, e.g. essential hypertension, diabetes, epilepsy, stroke'}, 'identificationModule': {'nctId': 'NCT01939093', 'acronym': 'MAP', 'briefTitle': 'Therapeutic Effect of Quetiapine on Methamphetamine-Induced Psychosis', 'organization': {'class': 'OTHER', 'fullName': 'Chulalongkorn University'}, 'officialTitle': 'Therapeutic Effect Between Quetiapine and Haloperidol on the Treatment of Methamphetamine - Induced Psychosis', 'orgStudyIdInfo': {'id': 'NRCT-53069'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Quetiapine', 'description': 'Quetiapine 100 mg per day is taken orally once a day for four weeks. The dose is increased every 5 days until no psychotic symptom is observed.', 'interventionNames': ['Drug: Diazepam', 'Dietary Supplement: Vitamin B1-6-12', 'Drug: Stugeron']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Haloperidol', 'description': 'Haloperidol 2 mg per day is taken orally once a day for four weeks. The dose is increased every 5 days until no psychotic symptom is observed.', 'interventionNames': ['Drug: Diazepam', 'Dietary Supplement: Vitamin B1-6-12', 'Drug: Stugeron']}], 'interventions': [{'name': 'Diazepam', 'type': 'DRUG', 'description': 'If subjects had aggressive or violent symptoms and immediate symptom control was needed, 10 mg of diazepam (intravenous injection) every 4 hours is allowed for symptom control.', 'armGroupLabels': ['Haloperidol', 'Quetiapine']}, {'name': 'Vitamin B1-6-12', 'type': 'DIETARY_SUPPLEMENT', 'description': "All subjects will be given the Institute's medication regimen, including vitamin B1-6-12 1 tablet three times a day after meals during the whole study period.", 'armGroupLabels': ['Haloperidol', 'Quetiapine']}, {'name': 'Stugeron', 'type': 'DRUG', 'description': "All subjects will be given the Institute's medication regimen, including stugeron 1 tablet three times a day after meals during the whole study period.", 'armGroupLabels': ['Haloperidol', 'Quetiapine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Pathum Thani', 'state': 'Changwat Pathum Thani', 'country': 'Thailand', 'facility': 'Thanyarak Institute on Drug Abuse', 'geoPoint': {'lat': 14.01346, 'lon': 100.53049}}], 'overallOfficials': [{'name': 'Viroj Verachai, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Thanyarak Institute on Drug Abuse'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chulalongkorn University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Thanyarak Institute', 'class': 'UNKNOWN'}, {'name': 'National Research Council of Thailand', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Rasmon Kalayasiri', 'investigatorAffiliation': 'Chulalongkorn University'}}}}