MULTICENTER STUDY, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE III, ON THE EFFICACY AND SAFETY OF QUETIAPIN AND LITHIUM FUMARATE AS MONOTHERAPY OF UP TO 104 WEEKS OF MAINTENANCE TREATMENT IN ADULT PATIENTS WITH BIPOLAR DISORDER I

ASTRAZENECA - PERU,0 个研究点目标入组 0 人开始时间: 2005年4月8日最近更新: 2023年9月4日

适应症

试验速览

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•1) Provide written informed consent before initiating any procedure
•2) A diagnosis of Bipolar I Disorder, Most Recent Manic Episode, Bipolar I Disorder, Most Recent Depressive Episode or Bipolar I Disorder, Most Recent Mixed Episode, with or without psychotic features
•3) Male or female> 18 years of age.
•4) At least 1 manic, depressive or mixed episode in the previous 2 years
•5) One of the following:
•a) A current manic, depressive or mixed episode, according to the DSM-IV criteria
•b) A manic, depressive or mixed episode in the previous 26 weeks
•6) Women of childbearing age should be using a reliable method of contraception.
•7) Able to understand and comply with the requirements of the study.

•1) Diagnosis of anxiety disorder.
•2) Known intolerance or lack of response to quetiapine or lithium fumarate.
•3) Pregnancy or lactation: women of childbearing age must have a negative test for human chorionic gonadotrophin (HCG) in serum.
•4) Substance or alcohol dependence.
•5) Abuse of opiates, amphetamine, barbiturates, cocaine, cannabinoids or hallucinogens.
•6) Use of any of the cytochrome P450 3A4 inhibitors in the 14 days prior to enrollment.
•7) Use of any of the inducers of cytochrome P450 3A4 in the 14 days prior to enrollment.
•8) Concentration of thyroid stimulating hormone (TSH) greater than 10% above the upper limit
•9) Unstable or inadequately treated medical disease
•10) Patient with unstable Diabetes Mellitus (DM), untreated or with other conditions that prevent him from participating in the study
•11) Medical conditions that would affect the absorption, distribution, metabolism or excretion of the treatment
•12) Use of an experimental drug within 30 days prior to enrollment.
•13) Patient previously enrolled in this study, study D1447C00126 or study D1447C00127.
•14) Patient who participates in the programming and conduction of the study

发起方

ASTRAZENECA - PERU,