N/A
N=19
Bipolar Disorder in Late Life
Bipolar Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00787930 ↗Enrolled (actual)
19
Serious AEs
5.3%
Results posted
Jul 2014
Primary outcome: Primary: Boyko DWM Hyperintensity Value >2 in Subjects Who Received Acute Treatment for Mania — 10; 9 participants — p=>0.05
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Valproic Acid (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Boyko DWM Hyperintensity Value >2 in Subjects Who Received Acute Treatment for Mania |
10; 9 | >0.05 |
| PRIMARY Boyko DWM Hyperintensity Value >2 in Subjects Who Received Continuation Treatment |
4; 4 | 1.00 |
| SECONDARY Boyko Subcortical (SC) Hyperintensity Value >2 in Subjects Who Received Continuation Treatment |
2; 4 | 0.6056 |
| SECONDARY fa LOFC in Subjects Who Received Continuation Treatment |
76.3; 81.4 | 0.081 |
| SECONDARY fa ROFC in Subjects Who Received Continuation Treatment |
76.1; 79.8 | 0.091 |
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.
Eligibility Criteria
Inclusion Criteria
- DSM-IV diagnosis of bipolar Disorder, Manic and mixed episodes.
- 18 years of age and older, male or female, any race.
- Capacity to give informed consent and follow study procedures.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00787930). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.