drugset / Trial / NCT00431522

Valproic Acid Sodium Salt in Bipolar Disorder

NCT00431522

Phase 4 Completed 58 enrolled Sanofi
Non-randomizedFactorialOpen-labelTreatment

Summary

* To determine the total and local gray matter volumes, and N-acetyl aspartate (NAA) levels in patients with bipolar disorders who are within euthimic, depressive or manic/hypomanic period and who are not taking drug; * To investigate the neuroprotective effects of long-term (6 weeks) use of valproate on total and local gray matter volumes and NAA levels. * To measure the brain electrical response to visual and auditory impulses before and after valproate treatment in patients within euthimic, depressive or manic/hypomanic period and who are not taking drug, and to compare the data with each other and with normal groups. * To determine the cognitive functions before and after the valproate treatment in the same patient group, to compare the data with each other and with age- and sex-paired normal controls; * To determine the relationship between these effects of valproate and clinical improvement; * To investigate the relationship between cognitive ability status and electrical activity of brain, to compare this with that in control group; to determine the relationship between the data and brain imaging (MRI/MRS) findings in conjunction with localization

Timeline

Start
2004-12
Primary completion
2006-10
Completion
2006-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Valproic Acid Small molecule

Indications