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Valproic acid

Valproic Acid Sodium Salt in Bipolar Disorder

Ensayo de Sanofi en Bipolar Disorder (del registro, en inglés).

Fase

Fase 4

Estado

Completado

Participantes

58

previstos

Centros

1

Fin del objetivo primario

oct 2006

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en dic 2004.

Qué mide

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) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registro* 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

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Ficha completa en ClinicalTrials.gov (NCT00431522), actualizada en may 2009.