A Randomized, Multicenter, Double-blind, Parallel Group Study ToCompare the Effects of Bifeprunox and Quetiapine on WeightChanges in Stable Schizophrenic Patients.

Solvay Pharmaceuticals. Inc.0 个研究点目标入组 875 人开始时间: 2007年6月12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: 875

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

•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) primary diagnosis of Schizophrenia (codes 295.10, 295.20, 295.30, 295.60,
•4. No hospitalization for an exacerbation of schizophrenia within two months prior to screening
•and during the screening period.
•5. No change in antipsychotic medication(s) and doses within eight weeks prior to screening and
•during the screening period.
•6. Normal physical and neurological examination, medical history, electrocardiogram, blood
•biochemistry, hematology test, vital signs at screening supportive of general good health at the
•discretion of the Investigator.
•7. Male or female subjects who are between 18-65 years, inclusive.
•8. PANSS total score = 80 at screening and baseline.
•9. Subjects who have a CGI-S score of = 4 (moderately ill) at screening and baseline.
•10. Subjects who have a score of = 4 (moderate) of the following PANSS items at screening and
•- P2 (conceptual disorganization)
•- P3 (hallucinatory behavior)
•- P6 (suspiciousness/persecution)
•- P7 (hostility)
•- G8 (uncooperativeness)
•- G9 (unusual thought content)
•11. Subjects who have a BMI > 27 kg/m2 at screening.
•12. Subjects who have a fasting triglyceride level > 130 mg/dl at screening.
•13. Females who are not breast-feeding or are of non-childbearing potential. All females must have
•a negative serum ß-HCG test prior to baseline. Non-childbearing is defined as:
•last natural menstruation at least 24 months prior to screening, or
•surgically sterilized (i.e. tubal sterilization), or
•hysterectomized 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 screening
•the first dose of medroxyprogesterone (Depo-Provera?) or other intramuscular injection
•administrated at least two months prior to screening and have been maintaining the
•recommended administration schedule
•implantation of levonorgestrel (Norplant?) system or an IUD for at least two months
•prior to screening
•barrier methods (combination of diaphragm and spermicide or condom and spermicide)
•prior to screening 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

•Current active acute psychotic episode or a current Axis I primary psychiatric diagnosis other
•than schizophrenia based on DSM-IV TR criteria.
•2. The potential for violent behavior (likely to harm themselves or others) based on history and
•mental status examination, or Investigator’s judgment.
•3. Suicidal ideation within the 12 months prior to screening or who have attempted suicide within
•3 years prior to screening.
•4. Unstable medical, psychiatric, neurological or behavioral disorders that may interfere with the
•conduct or interpretation of the study.
•5. A history of moderate or severe head trauma or other neurological disorders and systemic
•medical diseases which are likely to affect the central nervous system functioning.
•6. Malignant disease or a history of malignant disease, other than adequately treated carcinoma in
•situ of the cervix or basal cell carcinoma of the skin, within the past five years prior to
•7. Current diagnosis or history of substance (except nicotine, caffeine) or alcohol abuse based on
•DSM-IV TR criteria within six months prior to screening.
•8. 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.
•9. Exposure to any investigational drug within 60 days prior to screening.
•10. Treatment with bifeprunox in a previous study.
•11. Treatment with clozapine within 60 days prior to screening.
•12. Current treatment with depot antipsychotic medication.
•13. Treatment with electroconvulsive therapy (ECT) within 12 weeks prior to screening.
•14. Prior treatment with quetiapine within one year prior to screening.
•15. History of intolerance or failed to respond to previous treatment with quetiapine.
•16. Treatment with antidepressants or mood stabilizers within 2 months prior to screening.
•Solvay Pharmaceuticals, Inc. Protocol No. S154.3.021
•25 Protocol Date 28 July 2006
•17. Subjects who require disallowed concomitant medications (specified in Table 2) during the
•study. All allowed concomitant medications are preferably to be maintained at the same dose
•level throughout the study.
•18. Current evidence of clinically significant, untreated or uncontrolled neurological,
•hematological, autoimmune, endocrine, cardiovascular, liver, renal, gastrointestinal, pulmonary
•or infectious disease, or metabolic disturbances other than those originating from the
•antipsychotic treatment that would possibly interfere with the subject’s participation in the
•19. Known ischemic heart disease or a history of myocardial infarction (MI) within the previous 12
•months, coronary artery bypass surgery or percutaneous transluminal coronary angioplasty
•20. 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.
•21. 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 supine blood pressure or development of symptoms. The abnormal values should
•be confirmed at two separate measurements.
•22. A history of more than one episode of vasovagal syncope.
•23. Uncorrected or uncontrolled hypothyro

研究者

发起方

Solvay Pharmaceuticals. Inc.

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