Bipolar Disorder in Late Life (BPD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by Duke University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Duke University
ClinicalTrials.gov Identifier:
NCT00787930
First received: November 6, 2008
Last updated: November 7, 2008
Last verified: November 2008
  Purpose

The purpose of this study is to look at certain structural changes in the brain in people with bipolar disorder or those with a history of Bipolar disorder.

Also collecting a blood sample for genetic testing as relationship of genetics and changes in the brain.


Condition Intervention Phase
Bipolar Disorder
Drug: Valporic Acid
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bipolar Disorder in Late Life

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Young Mania Rating Scale (YMRS) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • MADRS [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 530
Study Start Date: January 1999
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Valporic Acid
    Tablets, 250mg-3000mg
    Other Name: Depakote
Detailed Description:

Individuals with bipolar disorder or those with a history of bipolar disorder may have certain structural changes in their brain. The purpose of this study is to look at those changes, as well as the assessment of risk factors for bipolar disorders, involving both social and psychological aspects of behavior, age, education, marital relations, nutrition, physical activity, etc., compared with persons not having bipolar disorder. These changes in the brain will be measured by Magnetic Resonance Imaging (MRI). A blood sample for genetic testing as we will be studying the relationship of genetics and changes in the structure the brain as evidenced by persons having MRI hyperintensities.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. DSM-IV diagnosis of bipolar Disorder, Manic and mixed episodes.
  2. 18 years of age and older, male or female, any race. Half the subjects will be above age 50.
  3. Capacity to give informed consent and follow study procedures.

Exclusion Criteria:

  1. History of alcohol/drug dependence
  2. Any metal or pacemaker in the body which precludes MRI
  3. Pregnancy
  4. Dementia or other primary psychiatric disorders including substance abuse/dependence, anxiety disorders, schizophrenia
  5. For controls, numbers one through four above as well as any history of depression or the use of antidepressants
  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: NCT00787930

Contacts
Contact: John L Beyer, M.D 919.668.0206 beyer001@mc.duke.edu
Contact: Nabila Lateef, B.S 919-684-9701 latee002@mc.duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27701
Contact: John L Beyer, M.D    919-668-0206    beyer001@mc.duke.edu   
Contact: Nabila Lateef, M.S    919-684-9701    latee002@mc.duke.edu   
Principal Investigator: John L Beyer, M.D         
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: John L Beyer, M.D Duke University
  More Information

No publications provided

Responsible Party: Dr. John Beyer, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT00787930     History of Changes
Other Study ID Numbers: IRB# Pro00007867, NIH#, M5Ro1-MH57027-08
Study First Received: November 6, 2008
Last Updated: November 7, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
BPD

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

ClinicalTrials.gov processed this record on July 26, 2014