A multi-center, open-label, parallel-group, randomized, flexible dose study to evaluate the safety and tolerability of switching from existing atypical antipsychotics to bifeprunox in subjects with schizophrenia or schizoaffective disorder.

Solvay Pharmaceuticals Inc0 个研究点目标入组 240 人开始时间: 2007年1月22日最近更新: 2012年3月19日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: Solvay Pharmaceuticals Inc
入组人数: 240

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 clinical trial of medicinal product

入排标准

性别: All

入选标准

•1.The subject or subject’s authorized legal representative must understand the nature of the study and must provide written informed consent prior to conduct of any study procedures.
•2.Each subject must be able to communicate with study personnel.
•3.Current Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV TR) diagnosis of Schizophrenia (codes 295.10, 295.20, 295.30, 295.60, 295.90) or Schizoaffective Disorder (code 295.70) for whom a switch is indicated (inadequate clinical response, failure to respond partially to adequate treatment, present or persistent negative symptoms or cognitive impairment despite good compliance, or intolerable adverse side effects based on the Investigator’s judgment).
•4.Subjects who do not have an exacerbation within the last eight weeks prior to baseline.
•5.Subjects who are taking only one prior atypical antipsychotic medication (olanzapine, risperidone, quetiapine, ziprasidone or aripiprazole) for eight weeks prior to baseline.
•6.Male or female subjects who are between 18-65 years, inclusive.
•7.Females who are not breast-feeding or are of non-childbearing potential. All females must have a negative serum ?-HCG test prior to baseline. Non-childbearing is defined as:
•last natural menstruation at least 24 months prior to baseline, or
•surgically sterilized (i.e. tubal sterilization), or
•hysterectomize state.
•A female subject of child-bearing potential may be enrolled provided that she is maintained on one of the following medically acceptable methods of birth control:
•oral or patch contraception at a stable dose for at least three months prior to baseline
•the first dose of medroxyprogesterone (Depo-Provera?) or other intramuscular injection administrated at least two months prior to baseline and have been maintaining the recommended administration schedule
•implantation of levonorgestrel (Norplant?) system or an IUD for at least two months prior to baseline
•barrier methods (combination of diaphragm and spermicide or condom and spermicide) prior to baseline and during the trial
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

排除标准

•Subjects who are acutely psychotic or subjects with a current Axis I primary psychiatric diagnosis other than schizophrenia or schizoaffective disorder based on DSM-IV TR criteria.
•2.Subjects who, based on history and mental status examination, or Investigator’s judgment are considered to be violent (likely to harm themselves or others), and/or had suicidal ideation within the 12 months prior to screening or who have attempted suicide within 3 years prior to screening.
•3.Subjects with unstable medical, psychiatric, neurological or behavioral disorders that may interfere with the conduct or interpretation of the study.
•4.Subjects who are receiving a depot antipsychotic medication within 12 weeks of baseline.
•5.Subjects who are receiving clozapine within six weeks of baseline.
•6.Subjects who have been hospitalized for exacerbation of psychosis within eight weeks prior to baseline.
•7.Subjects who could not be stabilized on their existing antipsychotic medication for at least eight weeks prior to baseline.
•8.Subjects who, in the Investigator’s opinion, have failed to respond to adequate courses of treatment with reference to dose and duration with antipsychotic agents belonging to two or more different drug classes.
•9.Current diagnosis or history of substance (except nicotine, caffeine) or alcohol abuse based on DSM-IV TR criteria within six months prior to screening.
•10.Positive urine drug screen at screening, baseline and/or during the study. Positive result for opioids and cannabinoids will be evaluated by the Investigator and Medical Monitor on the potential impact and continued participation of the subject in the study.
•11.Any clinically significant abnormal laboratory data, vital signs, physical examination at screening or baseline which in the opinion of the Investigator would interfere with safety assessments.
•12.Presence of QT intervals >480 ms for men, >500ms for women, history of congenital long QT syndromes, or risk of Torsades de Pointes because of family history of sudden death, etc.
•13.Exposure to any investigational drug within 60 days prior to screening.
•14.Subjects who received bifeprunox treatment in a previous study.
•15.Subjects who have received electroconvulsive therapy (ECT) within 90 days prior to baseline.
•16.Subjects who required SSRIs maintenance therapy or concomitant medications that are expected to cause significant drug-drug interactions (e.g. CYP3A4 or CYP2C9 inducers/inhibitors). All allowed concomitant medications are preferably to be maintained at the same dose level throughout the study.
•17.Subjects who require concomitant treatment with any of the disallowed medications during the study (listed in Section 5.4.4).
•18.Current evidence of clinically significant, untreated or uncontrolled neurological, hematological, autoimmune, endocrine, cardiovascular, liver, renal, gastrointestinal, pulmonary or infectious disease, or metabolic disturbance that would possibly interfere with the subject’s participation in the study.
•19.Known ischemic heart disease or history of myocardial infarction (MI) within the previous 12 months, coronary artery bypass surgery or percutaneous transluminal coronary angioplasty (PTCA).
•20.Symptomatic hypotension or orthostatic hypotension which is defined as a decrease of 30 mmHg or more in systolic blood pressure (SBP) and/or a decrease of 20 mmHg or more in diastolic blood pressure (DBP) after approximately one minute in upright position, compared to the previous

研究者

发起方

Solvay Pharmaceuticals Inc

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