NCT01188395

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 25, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

August 25, 2010

Status Verified

August 1, 2010

Enrollment Period

2.9 years

First QC Date

August 23, 2010

Last Update Submit

August 23, 2010

Conditions

Outcome Measures

Primary Outcomes (2)

  • Young's Mania Rating Scale (YMRS)

    The severity of manic symptoms of patients will be rated by using YMRS.

    baseline, 3 months

  • Hamilton Depression Rating Scale (HDRS)

    The severity of depressive symptoms of patients will be measured using HDRS.

    baseline, 3 months

Secondary Outcomes (2)

  • blood sample

    baseline, 3 months

  • DNA

    baseline

Study Arms (1)

subtypes of bipolar disorders

Bipolar I Disorder with alcoholism Bipolar I Disorder without alcoholism Bipolar II Disorder with alcoholism Bipolar II Disorder without alcoholism

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Bipolar disorders

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ru-Band Lu

Tainan, 704, Taiwan

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Officials

  • Ru-Band Lu, MD

    National Cheng-Kung University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 23, 2010

First Posted

August 25, 2010

Study Start

August 1, 2009

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

August 25, 2010

Record last verified: 2010-08

Locations