Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2026-02-13 @ 3:29 PM
Study NCT ID:
NCT00295412
Status:
COMPLETED
Last Update Posted:
2006-02-23
First Post:
2006-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Quetiapine on the Drug Abuse Patterns of Addicted Schizophrenic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069348', 'term': 'Quetiapine Fumarate'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}], 'ancestors': [{'id': 'D003987', 'term': 'Dibenzothiazepines'}, {'id': 'D013841', 'term': 'Thiazepines'}, {'id': 'D013846', 'term': 'Thiepins'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-09', 'lastUpdateSubmitDate': '2006-02-21', 'studyFirstSubmitDate': '2006-02-21', 'studyFirstSubmitQcDate': '2006-02-21', 'lastUpdatePostDateStruct': {'date': '2006-02-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-23', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Schizophrenia', 'Substance Use Disorders']}, 'descriptionModule': {'briefSummary': 'The lifetime of substance use disorders in schizophrenia is close to 50%. Substance abuse in schizophrenia is associated with negative consequences. Unfortunately, there no clear guidelines for the pharmacological treatment of this dual diagnosis population. Preliminary results suggest that second-generation antipsychotic drugs (mainly clozapine) may relieve drug cravings in schizophrenia. We performed a 12-week pilot study to evaluate the impact of quetiapine, a second-generation antipsychotic, on substance abuse parameters, psychiatric symptoms and side effects in patients schizophrenia and comorbid substance use disorders. Our expectation was a 20 % decrease in drug cravings from baseline to end-point.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with as schizophrenia spectrum disorder\n* Patients with a comorbid substance use disorder\n\nExclusion Criteria:\n\n* Patients already on quetiapine or clozapine\n* Patients hospitalized or acutely ill\n* Total score lower than 65 on the PANSS\n* Pregnancy\n* Female subjects of childbearing potential without adequate contraception\n* Abnormal liver function (hepatic enzymes more than 3 times the upper normal limits)\n* Any clinically meaningful unstable renal, hepatic, cardiovascular, respiratory, cerebrovascular disease or other serious, progressive physical disease.'}, 'identificationModule': {'nctId': 'NCT00295412', 'briefTitle': 'The Impact of Quetiapine on the Drug Abuse Patterns of Addicted Schizophrenic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Université de Montréal'}, 'officialTitle': 'The Impact of Quetiapine on the Drug Abuse Patterns of Addicted Schizophrenic Patients', 'orgStudyIdInfo': {'id': '5077-99904'}}, 'armsInterventionsModule': {'interventions': [{'name': 'quetiapine (drug)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H1N 3V2', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre de recherche Fernand-Seguin', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Emmanuel Stip, Md, MSc, CSPQ', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre de recherche Fernand-Seguin, Hôpital Louis-H Lafontaine, Departement of Psychiatry, Faculty of medicine, University of Montreal'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Montréal', 'class': 'OTHER'}, 'collaborators': [{'name': 'AstraZeneca', 'class': 'INDUSTRY'}]}}}