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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00271258 |
- 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 | Intervention | Phase |
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Bipolar Disorder |
Drug: SODIUM DIVALPROATE |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | STUDY OF THE TOLERANCE OF SODIUM DIVALPROATE (DEPAKOTE) IN ADOLESCENTS IN MANIC, MIXED OR HYPOMANIC EPISODES OF BIPOLAR DISORDER |
Ages Eligible for Study: | 13 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
General criteria:
Psychiatric criteria:
Somatic criteria:
Exclusion criteria linked to the treatment
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Responsible Party: | sanofi-aventis ( Medical Affairs Study Director ) |
Study ID Numbers: | L-9524, EudraCT #: 2004-004687-76 |
Study First Received: | December 29, 2005 |
Last Updated: | September 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00271258 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Affective Disorders, Psychotic Mental Disorders Bipolar Disorder |
Mood Disorders Psychotic Disorders Valproic Acid |
Pathologic Processes Disease |