Bipolar Disorder in Late Life

NCT ID: NCT00787930

Last Updated: 2014-07-31

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-10-31

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Bipolar Disorder

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Valproic Acid

Intervention Type DRUG

Tablets, 250mg-3000mg

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.

Valproic Acid

Intervention Type DRUG

Tablets, 250mg-3000mg

Interventions

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Valproic Acid

Tablets, 250mg-3000mg

Intervention Type DRUG

Other Intervention Names

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Depakote

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John L Beyer, M.D

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00007867

Identifier Type: -

Identifier Source: org_study_id

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