A Phase 3, randomized, 6-month, double blind trial in subjects with Bipolar I Disorder to evaluate the continued safety and maintenance of effect of Ziprasidone plus a mood stabilizer (vs placebo plus a mood stabilizer) following a minimum of 2 months of response to open-label treatment with both agents.(Clinical pharmacogenomics supplement amended) - NA

Pfizer AB0 个研究点目标入组 512 人2006年2月6日

概览

暂无简介。

注册库

who.int

开始日期

2006年2月6日

结束日期

待定

最后更新

14年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

•Demographic and General Inclusion Criteria
•Subject must:
•1\.Personally sign the written informed consent after the scope and nature of the investigation has been explained to them before any study\-specific procedure/evaluation is initiated or performed.
•2\.Be male or female.
•3\.Be at least 18 years of age and the age of legal consent.
•4\.Be a female who is not of child\-bearing potential (ie, surgically sterile or postmenopausal for at least one year), or be non\-pregnant and using an acceptable method of birth control for at least one month prior to the screening visit or be one who abstains from sex.Subject must meet all of the following criteria:
•·Agree to avoid pregnancy during the study and
•·Have a negative serum pregnancy test (\-HCG) at screening and
•·Use one of the birth control methods listed below:
•a. An oral contraceptive agent, implantable contraceptive (eg, Norplant)

•Psychiatric exclusion criteria:
•Subject must not:
•1\.Suffer from ultra\-fast rapid cycling (defined as 8 or more mood episodes over the previous 12 month period).
•2\.Be clinically stable on another treatment regimen that is also well tolerated (ie, clinical reason must exist to discontinue current treatment and enter subject into protocol).
•3\.Be at an imminent risk of harm to self or to others.
•4\.Have a diagnosis of mental retardation or organic brain syndrome.
•5\.Have a substance induced psychotic disorder or behavioral disturbance thought to be due to substance abuse.
•6\.Have a current (within 2 months prior to screening) DSM IV TRTM defined substance abuse/dependence (excluding nicotine and caffeine).
•7\.Have a history of treatment resistance to at least two other antipsychotic medications (after adequate dose and length of treatment).
•8\.Have a history of treatment resistance or intolerance to ziprasidone (adequate length and dose of treatment).