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

History of Changes

Tracking Information

First Received Date ^ICMJE

December 29, 2005

Last Updated Date

January 10, 2011

Start Date ^ICMJE

January 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

clinical examination

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00271258 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Safety Study of Sodium Divalproate in Bipolar Disorder in Adolescents

Official Title ^ICMJE

STUDY OF THE TOLERANCE OF SODIUM DIVALPROATE (DEPAKOTE) IN ADOLESCENTS IN MANIC, MIXED OR HYPOMANIC EPISODES OF BIPOLAR DISORDER

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Bipolar Disorder

Intervention ^ICMJE

Drug: SODIUM DIVALPROATE

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

200

Completion Date

January 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

13 Years to 18 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00271258

Other Study ID Numbers ^ICMJE

L_9524, EudraCT #: 2004-004687-76

Has Data Monitoring Committee

Responsible Party

Medical Affairs Study Director, sanofi-aventis

Study Sponsor ^ICMJE

Sanofi

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Marie SEBILLE, Dr

Sanofi

Information Provided By

Sanofi

Verification Date

January 2011

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

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