SOLMANIA - Comparison of Valproate-Amisulpride and Valproate-Haloperidol in Bipolar I Patients
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
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.