Bipolar Disorder
Conditions
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.
Interventions
DRUGSODIUM DIVALPROATE
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 18 Years
Healthy volunteers
No
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 *
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinical examination | — |
Countries
France
Outcome results
None listed