Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-01-06 @ 10:56 PM
Study NCT ID:
NCT06011460
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-08-25
First Post:
2023-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observation of Clozapine Treatment Safety in Bipolar Disorder.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D059020', 'term': 'Suicidal Ideation'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D013405', 'term': 'Suicide'}, {'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003024', 'term': 'Clozapine'}], 'ancestors': [{'id': 'D003984', 'term': 'Dibenzazepines'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-21', 'studyFirstSubmitDate': '2023-08-21', 'studyFirstSubmitQcDate': '2023-08-21', 'lastUpdatePostDateStruct': {'date': '2023-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety measures of clozapine treatment in patients with bipolar disorder.', 'timeFrame': '1 year', 'description': 'Incidence of possible occurrence of adverse events during treatment with clozapine in patients with bipolar disorder.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['clozapine', 'bipolar disorder', 'suicidality', 'adverse events'], 'conditions': ['Bipolar Disorder']}, 'referencesModule': {'references': [{'pmid': '31488793', 'type': 'BACKGROUND', 'citation': 'Wilkowska A, Wiglusz MS, Cubala WJ. Clozapine: promising treatment for suicidality in bipolar disorder. Psychiatr Danub. 2019 Sep;31(Suppl 3):574-578.'}, {'pmid': '31632038', 'type': 'BACKGROUND', 'citation': 'Wilkowska A, Cubala WJ. Clozapine As Transformative Treatment In Bipolar Patients. Neuropsychiatr Dis Treat. 2019 Oct 9;15:2901-2905. doi: 10.2147/NDT.S227196. eCollection 2019.'}, {'pmid': '31379632', 'type': 'BACKGROUND', 'citation': 'Wilkowska A, Wiglusz MS, Cubala WJ. Clozapine in Treatment-Resistant Bipolar Disorder With Suicidality. Three Case Reports. Front Psychiatry. 2019 Jul 19;10:520. doi: 10.3389/fpsyt.2019.00520. eCollection 2019.'}, {'pmid': '32182485', 'type': 'BACKGROUND', 'citation': 'Delgado A, Velosa J, Zhang J, Dursun SM, Kapczinski F, de Azevedo Cardoso T. Clozapine in bipolar disorder: A systematic review and meta-analysis. J Psychiatr Res. 2020 Jun;125:21-27. doi: 10.1016/j.jpsychires.2020.02.026. Epub 2020 Feb 27.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the registry is to record incidence of adverse events during treatment with clozapine in patients suffering from bipolar disorder.', 'detailedDescription': 'Bipolar disorder, with its spectrum, remains a life-long and significant mental health concern due to its unpredictable nature and varied symptomatology. Despite the wide array of available treatments, some cases of bipolar disorder remain resistant to traditional medications. Clozapine, traditionally used for treatment-resistant schizophrenia, has shown promising results in managing resistant cases of bipolar disorder, particularly reducing the risk of suicide. There are not enough controlled studies on clozapine, especially in treatment resistant bipolar depression.\n\nThere are certain limitations associated with the use of clozapine, primarily related to the possibility of adverse events including agranulocytosis, myocarditis, pneumonia, intestinal obstruction and seizures. Therefore, there is a need for more studies on safety and tolerability of this treatment in patients with bipolar disorder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with bipolar disorder treated with clozapine.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of treatment-resistant depressive episode in the course of bipolar disorder according to DSM-5.\n* Age from 18 to 65 years old.\n\nExclusion Criteria:\n\n* Patients unable to give fully written informed consent\n* Patients unable to comply with the requirements'}, 'identificationModule': {'nctId': 'NCT06011460', 'acronym': 'CloGD', 'briefTitle': 'Observation of Clozapine Treatment Safety in Bipolar Disorder.', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Gdansk'}, 'officialTitle': 'Observation of Clozapine Treatment Safety in Bipolar Disorder.', 'orgStudyIdInfo': {'id': 'NKBBN/355-183/2023'}}, 'armsInterventionsModule': {'armGroups': [{'label': "Patients' name", 'description': 'Diagnosis of treatment-resistant depressive episode in the course of bipolar disorder according to Diagnostic and Statistical Manual of Mental Disorders-5. Age from 18 to 65 years old.', 'interventionNames': ['Drug: Clozapine']}], 'interventions': [{'name': 'Clozapine', 'type': 'DRUG', 'description': 'Diagnosis of treatment-resistant depressive episode in the course of bipolar disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5).\n\nAge from 18 to 65 years old.', 'armGroupLabels': ["Patients' name"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '80-214', 'city': 'Gdansk', 'state': 'Pomeranian Voivodeship', 'country': 'Poland', 'facility': 'Department of Psychiatry, Medical University of Gdańsk', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}], 'overallOfficials': [{'name': 'Wiesław J Cubała, M.D. PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medican University of Gdańsk'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Gdansk', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}