Bipolar Disorder With Alcoholism in Han Chinese

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by National Cheng-Kung University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by:
National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier:
NCT01188395
First received: August 23, 2010
Last updated: NA
Last verified: August 2010
History: No changes posted
  Purpose

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.


Condition
Bipolar Disorders

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional

Resource links provided by NLM:


Further study details as provided by National Cheng-Kung University Hospital:

Primary Outcome Measures:
  • Young's Mania Rating Scale (YMRS) [ Time Frame: baseline, 3 months ] [ Designated as safety issue: No ]
    The severity of manic symptoms of patients will be rated by using YMRS.

  • Hamilton Depression Rating Scale (HDRS) [ Time Frame: baseline, 3 months ] [ Designated as safety issue: No ]
    The severity of depressive symptoms of patients will be measured using HDRS.


Secondary Outcome Measures:
  • blood sample [ Time Frame: baseline, 3 months ] [ Designated as safety issue: No ]
    PCR lab methodology

  • DNA [ Time Frame: baseline ] [ Designated as safety issue: No ]
    DRD2 TaqI-A PCR-RFLP ADH2 and ALDH2 PCR-RFLP MAO A genotypes


Estimated Enrollment: 105
Study Start Date: August 2009
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
subtypes of bipolar disorders
Bipolar I Disorder with alcoholism Bipolar I Disorder without alcoholism Bipolar II Disorder with alcoholism Bipolar II Disorder without alcoholism

Detailed Description:

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).

Our 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.

Mixed 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).

The 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Bipolar disorders

Criteria

Inclusion Criteria:

  1. Signed informed consent by patient or legal representative.
  2. Male or female patient aged ≧18 and ≦65 years.
  3. A diagnosis of Bipolar I or Bipolar II Disorder according to DSM-IV criteria made by a specialist in psychiatry.
  4. Patients who were diagnosed with alcohol dependence or abuse according to DSM-IV criteria made by a specialist in psychiatry.

Exclusion Criteria:

  1. Patients, except those are Bipolar disorder with alcoholsim who were diagnosed substance abuse/depence
  2. Patients with brain injury or regrated neurological diseases
  3. Patients who are with I axis major mental illess according to DSM-IV criteria
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01188395

Contacts
Contact: Ru-Band Lu, MD +886-6-2353535 ext 5108 rblu@mail.ncku.edu.tw

Locations
Taiwan
Ru-Band Lu Recruiting
Tainan, Taiwan, 704
Contact: Ru-Band Lu, MD    +886-6-2353535 ext 5108    rblu@mail.ncku.edu.tw   
Principal Investigator: Ru-Band Lu, MD         
Sponsors and Collaborators
National Cheng-Kung University Hospital
National Science Council, Taiwan
Investigators
Principal Investigator: Ru-Band Lu, MD National Cheng-Kung University Hospital
  More Information

No publications provided

Responsible Party: Ru-Band Lu/Professor, National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier: NCT01188395     History of Changes
Other Study ID Numbers: HR-98-002
Study First Received: August 23, 2010
Last Updated: August 23, 2010
Health Authority: Taiwan: Institutional Review Board

Additional relevant MeSH terms:
Bipolar Disorder
Disease
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 01, 2014