Bipolar DisordersNCT01188395
Bipolar Disorder With Alcoholism in Han Chinese
An observational study of Bipolar Disorders, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorders
- How many people
- 105 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2009to Jul 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Bipolar disorders
Who may be able to join
- Signed informed consent by patient or legal representative.
- Male or female patient aged ≧18 and ≦65 years.
- A diagnosis of Bipolar I or Bipolar II Disorder according to DSM-IV criteria made by a specialist in psychiatry.
- Patients who were diagnosed with alcohol dependence or abuse according to DSM-IV criteria made by a specialist in psychiatry.
Who cannot join
- Patients, except those are Bipolar disorder with alcoholsim who were diagnosed substance abuse/depence
- Patients with brain injury or regrated neurological diseases
- Patients who are with I axis major mental illess according to DSM-IV criteria
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Ru-Band Lu
Tainan, 704
Ru-Band Lu, MD, +886-6-2353535 ext. 5108, rblu@mail.ncku.edu.tw
Ru-Band Lu, MD
About this study
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.
Read the 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.
- Conditions
- Bipolar Disorders
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| subtypes of bipolar disorders | Bipolar I Disorder with alcoholism Bipolar I Disorder without alcoholism Bipolar II Disorder with alcoholism Bipolar II Disorder without alcoholism |
What is being measured
The primary outcome is the main question the study is designed to answer.
Young's Mania Rating Scale (YMRS)
The severity of manic symptoms of patients will be rated by using YMRS.
Measured: baseline, 3 months
Hamilton Depression Rating Scale (HDRS)
The severity of depressive symptoms of patients will be measured using HDRS.
Measured: baseline, 3 months
Secondary outcomes (2)
blood sample
PCR lab methodology
Measured: baseline, 3 months
DNA
DRD2 TaqI-A PCR-RFLP ADH2 and ALDH2 PCR-RFLP MAO A genotypes
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2010 (estimated)
- Study startAug 2009
- Primary completionJul 2012 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisordersStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Investigators
- Ru-Band Lu, MD, Principal investigator, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01188395
- Sponsor's protocol ID
- HR-98-002
- Status last verified
- Aug 2010
- First submitted
- 23 Aug 2010
- Last updated
- 25 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bipolar Disorder With Alcoholism in Han Chinese
- ClinicalTrials.gov ID
- NCT01188395
- Acronym / sponsor ID
- HR-98-002
- Conditions
- Bipolar Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Aug 2009
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 25 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| subtypes of bipolar disorders | – | –Bipolar I Disorder with alcoholism Bipolar I Disorder without alcoholism Bipolar II Disorder with alcoholism Bipolar II Disorder without alcoholism |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Bipolar disorders
Key inclusion criteria (4 listed)
- Signed informed consent by patient or legal representative.
- Male or female patient aged ≧18 and ≦65 years.
- A diagnosis of Bipolar I or Bipolar II Disorder according to DSM-IV criteria made by a specialist in psychiatry.
- Patients who were diagnosed with alcohol dependence or abuse according to DSM-IV criteria made by a specialist in psychiatry.
Key exclusion criteria (3 listed)
- Patients, except those are Bipolar disorder with alcoholsim who were diagnosed substance abuse/depence
- Patients with brain injury or regrated neurological diseases
- Patients who are with I axis major mental illess according to DSM-IV criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Young's Mania Rating Scale (YMRS)
Time frame: baseline, 3 months
The severity of manic symptoms of patients will be rated by using YMRS.
Hamilton Depression Rating Scale (HDRS)
Time frame: baseline, 3 months
The severity of depressive symptoms of patients will be measured using HDRS.
2 secondary outcomes
blood sample
Time frame: baseline, 3 months
DNA
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ru-Band Lu, MD principal investigator
National Cheng-Kung University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorders, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ru-Band Lu, MD (+886-6-2353535 ext. 5108, rblu@mail.ncku.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Young's Mania Rating Scale (YMRS) (time frame: baseline, 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2010.