EUCTR2005-000472-40-BE进行中（未招募）1 期
A Comparative, Randomized, Open-Label, Multicenter Study on the Efficacy and Safety of Switch Treatment with Aripiprazole in Schizophrenic Out-patients who areExperiencing Insufficient Efficacy with Risperidone and/or Safety and Tolerability Issues, While on Risperidone. Protocol version 1.0 dated 2005-03-31, andPharmacogenetics Blood Sample Amendment 01, version 1.0 dated 2005-04-11
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 430
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) Patients with a diagnosis of schizophrenia as defined by DSM-IV-TR criteria
- •(Appendix 2 of the protocol)
- •2) Out-patients having symptoms which in the clinical judgment of the treating
- •psychiatrist require treatment with antipsychotic (AP) medication.
- •3)Patients who have been taking Risperidone for minimum 6 weeks who are not
- •optimally controlled and/or experiencing safety/tolerability issues with Risperidone.
- •4) Men and women, aged 18 - 65 years.
- •5) Women of childbearing potential (WOCBP) must be using an adequate method of
- •contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study in such a manner that the risk of pregnancy is minimized.
- •6) WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity
- •25 IU/L or equivalent units of HCG) within 72 hours prior to the start of study
- •medication.
- •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
- •1) WOCBP who are unwilling or unable to use an acceptable method to avoid
- •pregnancy for the entire study period and for up to 4 weeks after the study.
- •2) WOCBP using a prohibited contraceptive method. No specific contraceptive
- •methods are prohibited in this study. Women practicing abstinence should use a
- •reliable method of contraception (except birth control pills, See Section 5.1of the protocol) if they choose to become sexually active during the study.
- •3) Women who are pregnant or breastfeeding
- •4) Women with a positive pregnancy test on enrollment or prior to study drug
- •administration.
- •5) Patients who are at risk for committing suicide: either having active suicidal ideation considered clinically significant or recently attempted suicide;
- •6) Patients with a diagnosis of schizoaffective disorder, bipolar disorder, depression with psychotic symptoms, or organic brain syndromes;
- •7) Patients who have met DSM-IV-TR criteria for any significant Psychoactive
- •Substance Use Disorder within the 3 months prior to Screening;
- •8) Patients considered treatment-resistant to antipsychotic medication (patients need to have shown a previous response to a antipsychotic medication other than clozapine) and patients with a significant history of intolerance to multiple antipsychotic treatments;
- •9) Patients with a history of neuroleptic malignant syndrome;
- •10) Patients with epilepsy, a history of seizures (except for a single childhood febrile
- •seizure), a history of stroke or who have a history or evidence of other medical
- •conditions that would expose them to an undue risk of a significant adverse event or
- •interfere with assessments of safety or efficacy during the course of the trial;
- •11) Patients who would be likely to require prohibited concomitant therapy during the trial (see Section 6.4 of the protocol);
- •12) Patients who have previously been treated with aripiprazole in an aripiprazole clinical study or who have participated in any clinical trial with an investigational agent within the past month.
- •13) Patients with detectable levels of cocaine, heroin or opioids in the drug screen.
- •Patients with a positive drug screen for stimulants or other drugs of abuse are to be
- •discussed with BMS and approval granted prior to treatment;
- •14) The following laboratory test results, vital sign and ECG findings are exclusionary:
- •QTc > 450 msec
- •Platelets < 75,000/mm3
- •Hemoglobin < 9g/dL
- •Neutrophils < 1000 cells/mcgL (or equivalent)
- •AST (SGOT) or ALT (SGPT) > 3x upper limit of normal
- •Creatinine > 2 mg/dL
- •Diastolic blood pressure > 105 mmHg
- •15) Patients who are known to be allergic or hypersensitive to aripiprazole or other dihydrocarbostyrils.
- •16) Prisoners or patients who are compulsorily detained (involuntarily incarcerated) fortreatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.
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