Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00271258
Status:
COMPLETED
Last Update Posted:
2011-01-11
First Post:
2005-12-29
Brief Title:
Safety Study of Sodium Divalproate in Bipolar Disorder in Adolescents
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
STUDY OF THE TOLERANCE OF SODIUM DIVALPROATE DEPAKOTE IN ADOLESCENTS IN MANIC MIXED OR HYPOMANIC EPISODES OF BIPOLAR DISORDER
Status:
COMPLETED
Status Verified Date:
2011-01
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:
ADOKOT
Brief Summary:
- 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
- Secondary objective To evaluate the efficacy of sodium divalproate in improving manic mixed or hypomanic symptoms
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EudraCT 2004-004687-76 | None | None | None |