Bipolar Disorder in Late Life (BPD)

Bipolar Disorder in Late Life (Evaluation of MRI Hyperintensities and DTI in Bipolar Disorder)

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.

Study Overview

• Status: Completed
• Conditions: Bipolar Disorder
• Intervention / Treatment: Drug: Valproic Acid

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).

• Study Type: Observational
• Enrollment (Actual): 19

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27701
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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 Names: 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 Names: Depakote

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Boyko DWM Hyperintensity Value >2 in Subjects Who Received Acute Treatment for Mania	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.	3 weeks
Boyko DWM Hyperintensity Value >2 in Subjects Who Received Continuation Treatment	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Boyko Subcortical (SC) Hyperintensity Value >2 in Subjects Who Received Continuation Treatment	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).	up to 12 months
fa LOFC in Subjects Who Received Continuation Treatment	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.	up to 12 months
fa ROFC in Subjects Who Received Continuation Treatment	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.	up to 12 months

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: John L Beyer, M.D, Duke University

Study record dates

Study Major Dates

• Study Start: October 1, 2005
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: November 6, 2008
• First Submitted That Met QC Criteria: November 7, 2008
• First Posted (Estimate): November 10, 2008

Study Record Updates

• Last Update Posted (Estimate): July 31, 2014
• Last Update Submitted That Met QC Criteria: July 3, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: BPD
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Bipolar and Related Disorders; Disease; Bipolar Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Enzyme Inhibitors; Tranquilizing Agents; Psychotropic Drugs; GABA Agents; Anticonvulsants; Antimanic Agents; Valproic Acid
• Other Study ID Numbers: Pro00007867