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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Disease
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 22, 2014