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Safety Study of Sodium Divalproate in Bipolar Disorder in Adolescents (ADOKOT)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00271258
First received: December 29, 2005
Last updated: January 10, 2011
Last verified: January 2011

December 29, 2005
January 10, 2011
January 2005
Not Provided
clinical examination
Not Provided
Complete list of historical versions of study NCT00271258 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Safety Study of Sodium Divalproate in Bipolar Disorder in Adolescents
STUDY OF THE TOLERANCE OF SODIUM DIVALPROATE (DEPAKOTE) IN ADOLESCENTS IN MANIC, MIXED OR HYPOMANIC EPISODES OF BIPOLAR DISORDER

- 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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Bipolar Disorder
Drug: SODIUM DIVALPROATE
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
January 2007
Not Provided

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.

Both
13 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00271258
L_9524, EudraCT #: 2004-004687-76
No
Medical Affairs Study Director, sanofi-aventis
Sanofi
Not Provided
Study Director: Marie SEBILLE, Dr Sanofi
Sanofi
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP