Safety Study of Sodium Divalproate in Bipolar Disorder in Adolescents

Study Overview
=================
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.

Official Title
-----------------
STUDY OF THE TOLERANCE OF SODIUM DIVALPROATE (DEPAKOTE) IN ADOLESCENTS IN MANIC, MIXED OR HYPOMANIC EPISODES OF BIPOLAR DISORDER

Conditions
-----------------
Bipolar Disorder

Intervention / Treatment
-----------------
* Drug: SODIUM DIVALPROATE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adolescent boys or girls aged 13 to 18 inclusive Weighing more than 40 kg Capable of understanding the protocol Who have given their written consent, as have their parents or legal guardian unless the adolescent has passed his/her 18th birthday Presenting the diagnostic characteristics of manic, mixed or hypomanic episodes of bipolar disorder established in accordance with the DSM IV, gathered in a semi-structured interview (Mini International Neuropsychiatric Interview - M.I.N.I.) With a score on the YMRS scale (Young Mania Rating Scale) >= 14 for the manic or mixed episode or >= 10 for the hypomanic episode Absence in blood of valproic acid at the inclusion visit Willing to use effective contraception in the case of girls of child-bearing potential. In this case the investigator should satisfy him/herself as to the psychological capacity of the patient to understand and undertake use of this contraception. Whose physiological test results are normal: hepatic function, blood count, lipid levels, fasting blood glucose level, blood urea, blood ammonia, blood protein, serum creatinine levels and plasma ions Exclusion Criteria: General criteria: Pregnant girls, or those breast-feeding or those for whom a pregnancy test is positive (blood beta HCG test) Simultaneous participation in another study or in the 2 months preceding selection of the patient Psychiatric criteria: Established or known mental retardation Autistic disorders Established schizophrenia Schizoaffective disorders Somatic criteria: Medical or organic disease of the CNS (epilepsy, tumour etc.) Any known renal, cardiac or haematological disease, or disease of the immune system Endocrine disorders and/or any biochemical abnormality known or existing at the moment of inclusion Exclusion criteria linked to the treatment Known hypersensitivity to valproate or to sodium divalproate or to one of the constituents of the drug Hepatic disease: acute hepatitis, chronic hepatitis, past personal or family history of severe hepatitis particularly caused by medicinal products, hepatic porphyria Treatment with lamotrigine, (Lamictal) Treatment with mefloquine, (Lariam) Any treatment based on valproate Treatment with methylphenidate (Ritalin) The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SODIUM DIVALPROATE|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical examination |  |  |