Bipolar Disorder in Late Life

NCT00787930 | Completed Results

• 1 other identifier: Pro00007867
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bipolar Disorder

Keywords

BPD

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Boyko Subcortical (SC) Hyperintensity Value >2 in Subjects Who Received Continuation Treatment

  up to 12 months

• fa LOFC in Subjects Who Received Continuation Treatment

  up to 12 months

• fa ROFC in Subjects Who Received Continuation Treatment

  up to 12 months

Study Arms (2)

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

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

Interventions

Valproic Acid DRUG

Tablets, 250mg-3000mg

Also known as: Depakote

Manic Subject with DWM Hyperintensities >2; Manic Subjects with DWM Hyperintensities <3

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• DSM-IV diagnosis of bipolar Disorder, Manic and mixed episodes.
• years of age and older, male or female, any race.
• Capacity to give informed consent and follow study procedures.

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27701, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA collected for genetic databank.

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Valproic Acid

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Limitations and Caveats

Acute MRI hypothesis unable to be tested due to high subject response. Five subject scans could not be evaluated by DTI computer program.

Results Point of Contact

• Title: John Beyer, MD
• Organization: Duke University Medical Center

john.beyer@dm.duke.edu

919-668-0209

Study Officials

• John L Beyer, M.D

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2008
• First Posted: November 10, 2008
• Study Start: October 1, 2005
• Primary Completion: September 1, 2010
• Study Completion: December 1, 2011
• Last Updated: July 31, 2014
• Results First Posted: July 31, 2014

Record last verified: 2014-07

Locations

US (1)