Safety Study of Sodium Divalproate in Bipolar Disorder in Adolescents

• Status: Completed
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi

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.