Safety Study of Sodium Divalproate in Bipolar Disorder in Adolescents (ADOKOT)
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|ClinicalTrials.gov Identifier: NCT00271258|
Recruitment Status : Completed
First Posted : December 30, 2005
Last Update Posted : January 11, 2011
- Main objective: To evaluate the clinical and physiological tolerance of sodium divalproate in manic, mixed or hypomanic episodes of bipolar disorder in adolescents treated for 6 months.
- Secondary objective: To evaluate the efficacy of sodium divalproate in improving manic, mixed or hypomanic symptoms.
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder||Drug: SODIUM DIVALPROATE||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||STUDY OF THE TOLERANCE OF SODIUM DIVALPROATE (DEPAKOTE) IN ADOLESCENTS IN MANIC, MIXED OR HYPOMANIC EPISODES OF BIPOLAR DISORDER|
|Study Start Date :||January 2005|
|Actual Study Completion Date :||January 2007|
- clinical examination
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00271258
|Study Director:||Marie SEBILLE, Dr||Sanofi|