NCT00271258已完成3 期
STUDY OF THE TOLERANCE OF SODIUM DIVALPROATE (DEPAKOTE) IN ADOLESCENTS IN MANIC, MIXED OR HYPOMANIC EPISODES OF BIPOLAR DISORDER
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- clinical examination
研究概览
简要总结
-
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
clinical examination
次要结局
未报告次要终点
研究者
研究点 (1)
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