Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT00271258
Status:
COMPLETED
Last Update Posted:
2011-01-11
First Post:
2005-12-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety Study of Sodium Divalproate in Bipolar Disorder in Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-10', 'studyFirstSubmitDate': '2005-12-29', 'studyFirstSubmitQcDate': '2005-12-29', 'lastUpdatePostDateStruct': {'date': '2011-01-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical examination'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Bipolar Disorder']}, 'descriptionModule': {'briefSummary': '\\- 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.\n\n\\- Secondary objective: To evaluate the efficacy of sodium divalproate in improving manic, mixed or hypomanic symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adolescent boys or girls aged 13 to 18 inclusive\n* Weighing more than 40 kg\n* Capable of understanding the protocol\n* Who have given their written consent, as have their parents or legal guardian unless the adolescent has passed his/her 18th birthday\n* 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.)\n* With a score on the YMRS scale (Young Mania Rating Scale) \\>= 14 for the manic or mixed episode or \\>= 10 for the hypomanic episode\n* Absence in blood of valproic acid at the inclusion visit\n* 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.\n* 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\n\nExclusion Criteria:\n\n* General criteria:\n\n * Pregnant girls, or those breast-feeding or those for whom a pregnancy test is positive (blood beta HCG test)\n * Simultaneous participation in another study or in the 2 months preceding selection of the patient\n* Psychiatric criteria:\n\n * Established or known mental retardation\n * Autistic disorders\n * Established schizophrenia\n * Schizoaffective disorders\n* Somatic criteria:\n\n * Medical or organic disease of the CNS (epilepsy, tumour etc.)\n * Any known renal, cardiac or haematological disease, or disease of the immune system\n * Endocrine disorders and/or any biochemical abnormality known or existing at the moment of inclusion\n* Exclusion criteria linked to the treatment\n\n * Known hypersensitivity to valproate or to sodium divalproate or to one of the constituents of the drug\n * Hepatic disease: acute hepatitis, chronic hepatitis, past personal or family history of severe hepatitis particularly caused by medicinal products, hepatic porphyria\n * Treatment with lamotrigine, (Lamictal)\n * Treatment with mefloquine, (Lariam)\n * Any treatment based on valproate\n * Treatment with methylphenidate (Ritalin)\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT00271258', 'acronym': 'ADOKOT', 'briefTitle': 'Safety Study of Sodium Divalproate in Bipolar Disorder in Adolescents', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'STUDY OF THE TOLERANCE OF SODIUM DIVALPROATE (DEPAKOTE) IN ADOLESCENTS IN MANIC, MIXED OR HYPOMANIC EPISODES OF BIPOLAR DISORDER', 'orgStudyIdInfo': {'id': 'L_9524'}, 'secondaryIdInfos': [{'id': 'EudraCT #: 2004-004687-76'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'SODIUM DIVALPROATE', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'country': 'France', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Marie SEBILLE, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Medical Affairs Study Director', 'oldOrganization': 'sanofi-aventis'}}}}