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
  Purpose

- 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.


Condition Intervention Phase
Bipolar Disorder
Drug: SODIUM DIVALPROATE
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: STUDY OF THE TOLERANCE OF SODIUM DIVALPROATE (DEPAKOTE) IN ADOLESCENTS IN MANIC, MIXED OR HYPOMANIC EPISODES OF BIPOLAR DISORDER

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • clinical examination

Estimated Enrollment: 200
Study Start Date: January 2005
Study Completion Date: January 2007
  Eligibility

Ages Eligible for Study:   13 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00271258

Locations
France
Sanofi-Aventis
Paris, France
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Marie SEBILLE, Dr Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00271258     History of Changes
Other Study ID Numbers: L_9524, EudraCT #: 2004-004687-76
Study First Received: December 29, 2005
Last Updated: January 10, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 16, 2014