Safety Study of Sodium Divalproate in Bipolar Disorder in Adolescents

NCT ID: NCT00271258

Last Updated: 2011-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2007-01-31

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.

Conditions

Bipolar Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

SODIUM DIVALPROATE

Intervention Type: DRUG

Eligibility 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

• 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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

Marie SEBILLE, Dr

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis

Paris, , France

Countries

France

Other Identifiers

EudraCT #: 2004-004687-76

Identifier Type: -

Identifier Source: secondary_id

L_9524

Identifier Type: -

Identifier Source: org_study_id