EUCTR2008-003340-11-DE进行中（未招募）不适用
The therapeutic window” of the atypical” antipsychotic paliperidone ER - A Positron Emission Tomography study with [18F]fallypride as the radiotracer
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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. Schizophrenia meeting DSM-IV criteria;
- •2. Male or female, aged 18-50 years;
- •3. CGI-S range between 2 or more and 5 or less;
- •4. At least 2 weeks antipsychotic medication with paliperidone ER or oral
- •risperidone in monotherapy and at least 5 days stable dose of paliperidone or
- •risperidone (application of medication should be carried out according the SmPC under consideration of contraindications, warning notices and interactions);
- •5. Ability to read, understand and sign the informed consent form;
- •6. Female subjects must be postmenopausal for at least 1 year, surgically sterile,
- •abstinent, or, if sexually active, agree to practice an effective hormonal method of
- •birth control before entry, throughout the study and at least 1 month after the in-
- •dividual study end. Female subjects of childbearing potential must have a
- •negative ßHCG-pregnancy test at visit 1.
- •Healthy control subjects:
- •- meet points 2, 5 and 6;
- •- are off all standard prescription drug therapy, OTC or recreational drugs for at least
- •one week prior to participation in the study.
- •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. has taken depot neuroleptic medication for at least 3 months prior to the start
- •of the study;
- •2. has taken another oral antipsychotic compound, antidepressant, anticonvulsant
- •(mood stabilizer) for at least 2 weeks prior to the start of the study;
- •3. is taking any other centrally active medication (except benzodiazepines,
- •paracetamole and zopiclone as rescue medication) within the trial;
- •4. has physical and psychological conditions that
- •odo interfere with the study procedures;
- •ocould influence the study results;
- •ocould endanger the subject during the study.
- •5. has a clinically relevant abnormality in clinical chemistry and hematology;
- •6. has a history or current symptoms of tardive dyskinesia;
- •7. has a history of neuroleptic malignant syndrome;
- •8. is suicidal or have a potential danger for third parties, judged to be at high risk
- •for adverse events, violence, or self-harm;
- •9. is pregnant or breast-feeding;
- •10. participates in a parallely conducted interventional study or has been
- •participating in an investigational study within 3 months prior to enrolment;
- •11. has a known hypersensitivity to paliperidone or risperidone;
- •12. has been abusing alcohol and/or drugs for at least four weeks prior to study
- •13. is inable to sign the Institutional Review Board-approved informed consent
- •form (ICF) due to the psychopathological condition;
- •14. is an employee of the investigator or study site, person with direct involvement
- •in the proposed study or other studies under the direction of that investigator or
- •study site, family member of the investigator or family member of the
- •employees of the investigator.
- •15. has anot drug related hyperprolactinaemia
- •16. is staying in a psychiatric clinic due to judicial order or order of a medical
- •Healthy control subject:
- •see points 4, 5, 9, 10, 12, 13 and 14.
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