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The primary objective is:
- To compare the efficacy of the association valproate-amisulpride (400 to 800 mg/day) to the association valproate-haloperidol (5 to 15 mg/day) in bipolar I patients suffering from a manic episode according to DSM IV TR (American Psychiatric Association [APA] 2000) and treated for a 3-month period.
The secondary objectives are:
- To evaluate the clinical and biological safety of the association valproate-amisulpride to the association valproate-haloperidol;
- To assess the patient status 3 weeks and 3 months after inclusion; and
- To assess patient satisfaction at 3 months.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Published on BioPortfolio: 2014-07-24T14:29:18-0400
Randomised, single-dose, crossover, placebo-controlled study to see if intravenous amisulpride has any effect on the heart rhythm, in particular the QT interval, in healthy adult volunteer...
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