Clinical trial NCT00271258: Safety Study of Sodium Divalproate in Bipolar Disorder in Adolescents
Official title: STUDY OF THE TOLERANCE OF SODIUM DIVALPROATE (DEPAKOTE) IN ADOLESCENTS IN MANIC, MIXED OR HYPOMANIC EPISODES OF BIPOLAR DISORDER
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar Disorder
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-12-30
Enrollment: 200
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: clinical examination
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Marie SEBILLE, Dr
role: STUDY_DIRECTOR
References: