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

January 10, 2011 updated by: Sanofi

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France
        • Sanofi-Aventis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
clinical examination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Director: Marie SEBILLE, Dr, Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

December 29, 2005

First Submitted That Met QC Criteria

December 29, 2005

First Posted (Estimate)

December 30, 2005

Study Record Updates

Last Update Posted (Estimate)

January 11, 2011

Last Update Submitted That Met QC Criteria

January 10, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L_9524
  • EudraCT #: 2004-004687-76

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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