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Protective Effect of Valproate on Brain Cells:A Magnetic Resonance Imaging and Spectroscopy Study in Patients With Bipolar Disorder Diagnosis
* 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
Details
| Lead sponsor | Sanofi |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 58 |
| Start date | 2004-12 |
| Completion | 2006-10 |
Conditions
- Bipolar Disorder
Interventions
- Valproic acid, sodium salt
Primary outcomes
- To assess regional N-acetyl aspartate (NAA) levels in drug free bipolar patients either in manic/hypomanic, or depressive or euthymic state — for 6 weeks
- To investigate valporate's effect on total and regional gray matter volume and NAA levels; — for 6 weeks
Countries
Turkey (Türkiye)