RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFECTIVENESS, SAFETY AND TOLERABILITY OF LICARBAZEPINE 750-2000 MG / DAY AS THERAPY ATTACHED TO LITHIUM OR VALPROATE IN THE TREATMENT OF THE MANIAC EPISODES OF THE BIPOLAR I DISORDER FOR 6 WEEKS

OVARTIS BIOSCIENSES PERU S.A.,0 个研究点目标入组 0 人开始时间: 2006年11月2日最近更新: 2023年9月4日

适应症

试验速览

阶段: 未知
状态: 已完成
发起方

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

入选标准

•1. Men and women from 18 to 70 years of age.
•2. Diagnosis of type I bipolar disorder, manic or mixed manic episodes.
•3. Score at least 20 on the Young Mania Rating Scale (YMRS).
•4. Necessity of psychiatric treatment.
•5. Cooperation and desire to complete all aspects of the study.
•6. Written informed consent provided before participation in the study.

排除标准

•1. Another current diagnosis different from bipolar I disorder.
•2. History of schizophrenia or schizoaffective disorder.
•3. Concomitant use of psychoactive medication other than lorazepam, lithium or valproate.
•4. Drug dependence during the month prior to the selection.
•5. Positive urine drug in the screening visit for amphetamines, cocaine, hallucinogens, or opiates.
•6. History of attempted suicide within one month before the screening visit or immediate risk of harm to self or others at the time of selection.
•7. Mental retardation according to the DSM-IV criteria.
•8. Female patients with potential to become pregnant who are not using effective contraception during the study, are breastfeeding or have a positive pregnancy test (B-hCG) in the selection or at baseline.
•9. Serum sodium ≤ 130 mmol / L basal or history of multiple episodes of hyponatremia.
•10. Any sensory or motor deficit that could prevent the patient from completing any evaluation of the study.
•11. Any non-psychiatric coexisting disease that has not been maintained in a stable condition for at least 3 months prior to baseline.
•12. Abnormal clinically significant conditions of the gastrointestinal system, liver, or kidneys that could produce the possibility of alterations of absorption, excess of accumulation, or alteration of the metabolism or excretion of the drug.
•13. Twice above the upper limit of normal in the selection with repeated measurements of the following laboratory parameters: SGOT, SGPT, LDH, alkaline phosphatase, or bilirubin; BUN values ≥ 30 mg / dL or creatinine clearance <30 mL / min.
•14. Any other abnormal clinical laboratory finding that is significant in the selection that continues abnormal after repeated measurements.
•15. Any of the following serological findings: a) Hepatitis A positive antibody (IgM). b) Hepatitis B surface antigen (HBsAg) positive. c) Hepatitis B central antibody (Anti-HBcAb) positive, together with a negative surface antigen of hepatitis B (Anti-HBsAb), in case of abnormal liver enzymes or recent symptoms of hepatitis.
•16. History of past or recent diagnosis of epilepsy, major head trauma, or progressive neurological disease.
•17. Known hypersensitivity to lithium or valproate or related drugs
•chemically with licarbazepine.
•18. Exhibition for 30 days before selection to any drug not registered for the country where the study is being conducted.
•19. Electroconvulsive therapy (ECT) within 3 months before baseline.
•20. Any form of psychotherapy within the month preceding the selection.
•21. Hospitalization due to mania due to a court order.
•22. Patients under supervision or legal guardianship.
•23. Previous treatment in any study with licarbazepine.

研究者

发起方

OVARTIS BIOSCIENSES PERU S.A.,

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