SOLMANIA - Comparison of Valproate-Amisulpride and Valproate-Haloperidol in Bipolar I Patients
This study has been completed.
Information provided by:
First received: July 18, 2005
Last updated: April 8, 2008
Last verified: April 2008
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A 3-Month, Open, Randomised Trial Comparing the Efficacy and Safety of the Association Valproate-Amisulpride to the Association Valproate-Haloperidol in Bipolar I Patients Suffering From a Manic Episode|
Resource links provided by NLM:
Drug Information available for: Haloperidol Valproic acid Valproate sodium Haloperidol decanoate Divalproex sodiumU.S. FDA Resources
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Combination of the percentage of responders defined by a decrease of at least 50% of the Y-MRS (Young Mania Rating Scale) between D0 and D END and the completion of the 3-month treatment period.
Secondary Outcome Measures:
- Other efficacy criteria (such as the changes in Y-MRS scores between D0 and D 21, between D0 and D END.The percentage of remission defined as the Y-MRS < or = 12 at D END...). Safety data (clinical, ECG and laboratory data)
|Study Start Date:||May 2004|
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00126009
|Prague, Czech Republic|
Sponsors and Collaborators
|Study Director:||Gilles Perdriset, MD||Sanofi|