Safety Study of Sodium Divalproate in Bipolar Disorder in Adolescents

Bipolar Disorder Clinical Trial

— ADOKOT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00271258
• Other study ID #: L_9524
• Secondary ID: EudraCT #: 2004-
• Status: Completed
• Phase: Phase 3
• First received: December 29, 2005
• Last updated: January 10, 2011
• Start date: January 2005
• Est. completion date: January 2007

Study information

• Verified date: January 2011
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 18 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Drug:
• SODIUM DIVALPROATE

Locations

Country	Name	City	State
France	Sanofi-Aventis	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical examination