SOLMANIA - Comparison of Valproate-Amisulpride and Valproate-Haloperidol in Bipolar I Patients
Completed
Sanofi
Phase 2
2004-05-01
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.
Early Pharmacological and Psychological Intervention for Late Prodromal States of Psychosis
Completed
Department of Psychiatry University of Bonn
Phase 4
2001-01-01
The study will provide an empirical basis for a pharmacological treatment option. An
open-label, randomized, multi-centre parallel group design is used. An intensified clinical
management (CM), which allows needs-based psychological crisis intervention, is compared to a
combination of such a CM and the atypical neuroleptic amisulpride. The central hypothesis is
that the combination of a clinical management with an atypical neuroleptic is the superior
treatment.
Early Pharmacological and Psychological Intervention for Late Prodromal States of Psychosis
Completed
German Federal Ministry of Education and Research
Phase 4
2001-01-01
The study will provide an empirical basis for a pharmacological treatment option. An
open-label, randomized, multi-centre parallel group design is used. An intensified clinical
management (CM), which allows needs-based psychological crisis intervention, is compared to a
combination of such a CM and the atypical neuroleptic amisulpride. The central hypothesis is
that the combination of a clinical management with an atypical neuroleptic is the superior
treatment.
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