Status:
COMPLETED
Safety Study of Sodium Divalproate in Bipolar Disorder in Adolescents
Lead Sponsor:
Sanofi
Conditions:
Bipolar Disorder
Eligibility:
All Genders
13-18 years
Phase:
PHASE3
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. \- Seconda...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
End Date :
January 1 2007
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00271258
Start Date
January 1 2005
End Date
January 1 2007
Last Update
January 11 2011
Active Locations (1)
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1
Sanofi-Aventis
Paris, France