Ignite Creation Date:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2026-01-01 @ 6:19 AM
Study NCT ID:
NCT01188395
Status:
UNKNOWN
Last Update Posted:
2010-08-25
First Post:
2010-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bipolar Disorder With Alcoholism in Han Chinese
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 105}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'completionDateStruct': {'date': '2012-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-08-23', 'studyFirstSubmitDate': '2010-08-23', 'studyFirstSubmitQcDate': '2010-08-23', 'lastUpdatePostDateStruct': {'date': '2010-08-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Young's Mania Rating Scale (YMRS)", 'timeFrame': 'baseline, 3 months', 'description': 'The severity of manic symptoms of patients will be rated by using YMRS.'}, {'measure': 'Hamilton Depression Rating Scale (HDRS)', 'timeFrame': 'baseline, 3 months', 'description': 'The severity of depressive symptoms of patients will be measured using HDRS.'}], 'secondaryOutcomes': [{'measure': 'blood sample', 'timeFrame': 'baseline, 3 months', 'description': 'PCR lab methodology'}, {'measure': 'DNA', 'timeFrame': 'baseline', 'description': 'DRD2 TaqI-A PCR-RFLP ADH2 and ALDH2 PCR-RFLP MAO A genotypes'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Bipolar Disorders']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to explore relation between the comorbidity of different bipolar disorders with alcoholism and neuropsychiatric function and candidate genes. The investigators plan to establish genetic validity for this subtype of alcoholism. In addition, by comparing this subtyped alcoholism to normal control, the investigators plan to examine the genetic validity of such comorbidity. The investigators plan to find specific clinical characteristic from neuropsychiatric aspects of such subtype for future early diagnosis, prediction and prevention.', 'detailedDescription': 'From family, twin and adoption studies supported a strong hereditary component in unsubtyped alcohol dependency (Cloninger et al., 1981; Reich et al., 1999; Huang et al., 2004). Dopamine, serotonin related genes and ADH, ALDH genes have been considered as candidate genes for alcohol dependency (Goldman, 1995; Reich et al., 1999; Noble et al., 2000). However, both in simple or family-base association studies have generated controversy about the relationship between candidate genes and alcoholism (Edenberg et al., 1998; Reich et al., 1999; Noble et al., 2000). One of the possible explanations may be due to that those studies did not subtype alcohol dependency, even though alcoholism is a complex phenotype with a heterogeneous etiology (Huang et al., 2004; Lu et al., 2005a).\n\nOur previous research results had already categorized AD among Han Chinese in Taiwan into four subtypes, pure alcoholism (Pure ALC), anxiety-depression alcoholism (ANX/DEP ALC), antisocial alcoholism (Antisocial ALC) and mixed type alcoholism (Mixed ALC) （Huang et al., 2004; Lu et al., 2005; Wang et al., 2007）. Except for Mixed ALC, we have established fundamental genetic validity, and confirmed several candidate genes including MAOA、ADH、ALDH、DRD2.\n\nMixed ALC is categorized by alcoholism comorbid with other psychiatric disorders including schizophrenia and bipolar disorder. Among them all, bipolar disorders most frequently comorbid with alcohol and substance dependence. The high comorbidity between alcohol dependence among patients with bipolar disorder worsens the treatment effect and prognosis. Bipolar disorders are divided into several categories, including bipolar I disorder (BP-I), bipolar II disorder (BP-II), and cyclothymic disorder. Previous literatures have documented that BP-I and BP-II might have different etiology, phenomenology, characteristics and neuropsychiatric functional impairments in the course of the illness (APA, 1994).\n\nThe aim of this study is to explore relation between the comorbidity of different bipolar disorders with alcoholism and neuropsychiatric function and candidate genes. We plan to establish genetic validity for this subtype of alcoholism. In addition, by comparing this subtyped alcoholism to normal control, we plan to examine the genetic validity of such comorbidity. We plan to find specific clinical characteristic from neuropsychiatric aspects of such subtype for future early diagnosis, prediction and prevention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Bipolar disorders', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signed informed consent by patient or legal representative.\n2. Male or female patient aged ≧18 and ≦65 years.\n3. A diagnosis of Bipolar I or Bipolar II Disorder according to DSM-IV criteria made by a specialist in psychiatry.\n4. Patients who were diagnosed with alcohol dependence or abuse according to DSM-IV criteria made by a specialist in psychiatry.\n\nExclusion Criteria:\n\n1. Patients, except those are Bipolar disorder with alcoholsim who were diagnosed substance abuse/depence\n2. Patients with brain injury or regrated neurological diseases\n3. Patients who are with I axis major mental illess according to DSM-IV criteria'}, 'identificationModule': {'nctId': 'NCT01188395', 'briefTitle': 'Bipolar Disorder With Alcoholism in Han Chinese', 'organization': {'class': 'OTHER', 'fullName': 'National Cheng-Kung University Hospital'}, 'orgStudyIdInfo': {'id': 'HR-98-002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'subtypes of bipolar disorders', 'description': 'Bipolar I Disorder with alcoholism Bipolar I Disorder without alcoholism Bipolar II Disorder with alcoholism Bipolar II Disorder without alcoholism'}]}, 'contactsLocationsModule': {'locations': [{'zip': '704', 'city': 'Tainan', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Ru-Band Lu, MD', 'role': 'CONTACT', 'email': 'rblu@mail.ncku.edu.tw', 'phone': '+886-6-2353535', 'phoneExt': '5108'}, {'name': 'Ru-Band Lu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ru-Band Lu', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}], 'centralContacts': [{'name': 'Ru-Band Lu, MD', 'role': 'CONTACT', 'email': 'rblu@mail.ncku.edu.tw', 'phone': '+886-6-2353535', 'phoneExt': '5108'}], 'overallOfficials': [{'name': 'Ru-Band Lu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cheng-Kung University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cheng-Kung University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Science and Technology Council, Taiwan', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Ru-Band Lu/Professor', 'oldOrganization': 'National Cheng-Kung University Hospital'}}}}