Valproic Acid Sodium Salt in Bipolar Disorder

Status Completed

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Bipolar Disorder

Clinical Trial Details

NCT number	NCT00431522
Study type	Interventional
Source	Sanofi
Contact
Status	Completed
Phase	Phase 4
Start date	December 2004
Completion date	October 2006

View Details

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