Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
Age
13–18
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
* 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.
Clareo Health | Safety Study of Sodium Divalproate in Bipolar Disorder in Adolescents
