SOLMANIA - Comparison of Valproate-Amisulpride and Valproate-Haloperidol in Bipolar I Patients
|ClinicalTrials.gov Identifier: NCT00126009|
Recruitment Status : Completed
First Posted : August 2, 2005
Last Update Posted : April 10, 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.
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder||Drug: Amisulpride||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||May 2004|
- 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.
- 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)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00126009
|Prague, Czech Republic|
|Study Director:||Gilles Perdriset, MD||Sanofi|