Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-25 @ 5:26 PM
Study NCT ID:
NCT00300404
Status:
COMPLETED
Last Update Posted:
2006-05-22
First Post:
2006-03-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Specific Anti-Toxoplasmatic Add-on Medication in Toxoplasma Gondii Seropositive Individuals With Schizophrenia or Major Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D019964', 'term': 'Mood Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011739', 'term': 'Pyrimethamine'}, {'id': 'D002955', 'term': 'Leucovorin'}], 'ancestors': [{'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-03', 'completionDateStruct': {'date': '2005-09'}, 'lastUpdateSubmitDate': '2006-05-19', 'studyFirstSubmitDate': '2006-03-07', 'studyFirstSubmitQcDate': '2006-03-07', 'lastUpdatePostDateStruct': {'date': '2006-05-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-03-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Psychopathology ratings'}], 'secondaryOutcomes': [{'measure': 'TG infection parameters'}]}, 'conditionsModule': {'keywords': ['Schizophrenia', 'Psychosis', 'Depression', 'Affective Disorder'], 'conditions': ['Schizophrenia', 'Major Depression']}, 'descriptionModule': {'briefSummary': 'We investigate whether the add-on specific antitoxoplasmatic medication has positive effects in individuals with schizophrenia or major depression seropositive for Toxoplasma gondii (TG) infection. As TG modulates neurotransmitter metabolism affecting serotonin and dopamine we hypothesize that this chronic persistent infection might play a role for depressive and psychotic symptomatology. Therefore, on the basis of an ex juvantibus approach, specific anti TG medication might further improve psychiatric symptomatology in affected patients. This is investigated in a double-blind, placebo-controlled, randomized treatment trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Schizophrenia or Major Depression\n* Both genders\n* Adult\n* Patients are able to give informed consent\n\nExclusion Criteria:\n\n* Additional diagnosis of substance abuse/dependency\n* Continuous treatment with medication not compatible with study medication\n* Medical status not compatible with study medication\n* Any condition that increases study risk considerably\n* Pregnancy, nursing'}, 'identificationModule': {'nctId': 'NCT00300404', 'briefTitle': 'Effect of Specific Anti-Toxoplasmatic Add-on Medication in Toxoplasma Gondii Seropositive Individuals With Schizophrenia or Major Depression', 'organization': {'class': 'OTHER', 'fullName': 'Zentrum für Integrative Psychiatrie'}, 'officialTitle': 'Effect of Add-on Anti-Toxoplasmosis Treatment on Parameters Defining Toxoplasma Gondii Infection and on Psychopathology in Patients With Schizophrenia or Major Depression Serologically Positive for Toxoplasma Gondii - Phase 3 Study', 'orgStudyIdInfo': {'id': 'TOXO-KI-TT'}, 'secondaryIdInfos': [{'id': 'SMRI grant # 01T-404'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'daraprim', 'type': 'DRUG'}, {'name': 'pyrimethamine', 'type': 'DRUG'}, {'name': 'folinic acid', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Dunja Hinze-Selch, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zentrum für Integrative Psychiatrie'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zentrum für Integrative Psychiatrie', 'class': 'OTHER'}, 'collaborators': [{'name': 'Stanley Medical Research Institute', 'class': 'OTHER'}]}}}