Bipolar Disorder in Late Life (BPD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00787930
First received: November 6, 2008
Last updated: July 3, 2014
Last verified: July 2014
  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.


Condition Intervention
Bipolar Disorder
Drug: Valproic Acid

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Bipolar Disorder in Late Life (Evaluation of MRI Hyperintensities and DTI in Bipolar Disorder)

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Boyko DWM Hyperintensity Value >2 in Subjects Who Received Acute Treatment for Mania [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    Subject with acute mania were treated for 3 weeks with STEP-BD protocol using valproic acid as the primary intervention. Subject MRI's were evaluated for the presence of deep white matter hyperintensities (DWM) (>2 on the the Boyko Classification). Boyko lesion classification system assesses DWM hyperintensities as follows: 0 = absent, 1 = punctate, 2 = rounded <5 mm, 3 = irregular >5 mm, 4 = confluent lesions.

  • Boyko DWM Hyperintensity Value >2 in Subjects Who Received Continuation Treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Subject were evaluated for relapse of their mood disorder and for the presence of DWM Hyperintensities (>2 on the the Boyko Classification. Boyko lesion classification system assesses DWM hyperintensities as follows: 0 = absent, 1 = punctate, 2 = rounded <5 mm, 3 = irregular >5 mm, 4 = confluent lesions. Subjects were also assessed for relapse, as defined by the Montgomery-Asberg Depression Rating Scale (MADRS)and the Young Mania Rating Scale (YMRS). Relapse was defined by protocol as either a MADRS scale >15 or a YMRS scale >15.


Secondary Outcome Measures:
  • Boyko Subcortical (SC) Hyperintensity Value >2 in Subjects Who Received Continuation Treatment [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
    Subject were evaluated for relapse of their mood disorder and for the presence of subcortical (SC) Hyperintensities (>2 on the the Boyko Classification). Boyko lesion classification system assesses SC hyperintensities as follows: 0 = absent, 1 = punctate, 2 = rounded <5 mm, 3 = irregular >5 mm, 4 = confluent lesions. Subjects were also assessed for relapse, as defined by the Montgomery-Asberg Depression Rating Scale (MADRS)and the Young Mania Rating Scale (YMRS).

  • fa LOFC in Subjects Who Received Continuation Treatment [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
    As an exploratory analysis, subject MRI's were also evaluated using diffusion tensor imaging (DTI) for differences in fractional anisoptery (fa) in the Left Orbitofrontal area (LOFC). FA is a scalar value between zero and one hundred that describes the degree of anisotropy of a diffusion process. A value of zero means that the diffusion is isotropic (unrestricted in all directions). A value of one hundred means that diffusion occurs only along one axis and is fully restricted along all other directions.

  • fa ROFC in Subjects Who Received Continuation Treatment [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
    As an exploratory analysis, subject MRI's were also evaluated using diffusion tensor imaging (DTI) for differences in fractional anisoptery (fa) in the Right Orbitofrontal area (ROFC). FA is a scalar value between zero and one hundred that describes the degree of anisotropy of a diffusion process. A value of zero means that the diffusion is isotropic (unrestricted in all directions). A value of one hundred means that diffusion occurs only along one axis and is fully restricted along all other directions.


Biospecimen Retention:   Samples With DNA

DNA collected for genetic databank.


Enrollment: 19
Study Start Date: October 2005
Study Completion Date: December 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Manic Subject with DWM Hyperintensities >2
Subjects with acute mania who were treated with naturalistic protocol (starting with valproic acid) who had a BOYKO DWM Hyperintensity rating >2 and a YMRS <15 at week 3.
Drug: Valproic Acid
Tablets, 250mg-3000mg
Other Name: Depakote
Manic Subjects with DWM Hyperintensities <3
Subjects with acute mania who were treated with naturalistic protocol (starting with valproic acid)who had a BOYKO DWM Hyperintensity rating <3 and a YMRS <15 at week 3.
Drug: Valproic 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).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Subjects recruited from the adult inpatient and outpatient psychiatric clinics at Duke University Medical Center and John Umstead Hospital (Butner, NC).

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.
  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

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27701
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: John L Beyer, M.D Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00787930     History of Changes
Other Study ID Numbers: Pro00007867
Study First Received: November 6, 2008
Results First Received: December 31, 2012
Last Updated: July 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
BPD

Additional relevant MeSH terms:
Bipolar Disorder
Disease
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Pathologic Processes
Valproic Acid
Anticonvulsants
Antimanic Agents
Central Nervous System Agents
Central Nervous System Depressants
Enzyme Inhibitors
GABA Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 22, 2014