Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00126009
Status:
COMPLETED
Last Update Posted:
2008-04-10
First Post:
2005-07-18
Brief Title:
SOLMANIA - Comparison of Valproate-Amisulpride and Valproate-Haloperidol in Bipolar I Patients
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2008-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective is
To compare the efficacy of the association valproate-amisulpride 400 to 800 mgday to the association valproate-haloperidol 5 to 15 mgday 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
To compare the efficacy of the association valproate-amisulpride 400 to 800 mgday to the association valproate-haloperidol 5 to 15 mgday 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None