PER-102-06已完成未知
Six Week, Double-Blind, Placebo Controlled Phase III Trial Evaluating The Efficacy, Safety And Pharmacokinetics Of Flexible Doses Of Oral Ziprasidone In Adolescent Subjects With Schizophrenia
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- PFIZER S.A.,
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. The subject and the authorized legal representative must understand the nature of the study and must be able to obey the protocol requirements.
- •2. The subject must be between 13 and 17 years old at the time of selection.
- •3. The subject must have a primary diagnosis of schizophrenia.
- •4. Current symptoms must have been present for at least 7 days prior to selection.
- •5. At screening and baseline visits, subjects must have a BPRS-A score ≥ 35 and a score of ≥ 4 in at least one of the following concepts: thinking of strange content, hallucinations, mistrust, or conceptual disorganization.
- •6. The subject must be likely to benefit from antipsychotic therapy.
- •7. The subject must have a Body Mass Index (BMI) z-score between -1.65 and +1.65.
- •8. The subject is willing and able to discontinue any medication that is prohibited in this study.
- •9. Women with potential for maternity may be included, provided they are not pregnant, or breastfeeding, and are practicing effective contraception.
排除标准
- •1. Subjects that are clinically stable, with treatment regimens that are being well tolerated.
- •2. Subjects with a substance-induced psychopathic disorder or from whom the behavioral disturbance is thought to have been due to the abuse of a substance.
- •3. Subjects with psychoactive substance abuse.
- •4. Subjects with an evaluation of 7 in the concept of Suicide Planning.
- •5. Subjects who are at imminent risk of suicide.
- •6. Subjects with significant mental retardation.
- •7. Subjects with autism or strong developmental disorder.
- •8. Subjects with any serious and unstable disease.
- •9. Subjects with a history of episodes of syncope or unexplained loss of consciousness.
- •10. Subjects with any medical condition or dietary habit, that have an important potential to alter the absorption of the study drug, or the subjects who are taking any medication that could alter its absorption.
- •11. Subjects with uncorrected hypothyroidism or hyperthyroidism, or whose thyroid function and medication regimen has been stable for less than one month.
- •12. Subjects with some selection laboratory value that deviates significantly from the limits of the normal reference range.
- •13. Subjects with K, Mg or Ca values below the normal range.
- •14. Subjects with a history of chronic hepatitis, identified serological evidence of acute hepatitis or chronic hepatitis, or subjects with identified hepatitis C antibodies and elevated LFTs.
- •15. Subjects who identify themselves as HIV positive.
- •16. Subjects with clinically significant hypokalemia or uncorrected hypomagnesemia and stabilized by the addition of food supplements or some other corrective measure, before the baseline.
- •17. Subjects with a history of important cardiovascular disease.
- •18. Subjects with a history of cardiac arrhythmias, conduction abnormalities or personal history of QT segment prolongation.
- •19. Subjects with an identified genetic risk of prolonged QT syndrome.
- •20. Subjects with clinically significant ECG abnormalities at the screening visit or at the baseline visit.
- •21. Subjects with a persistent QTc ≥ 460 msec at the screening visit or at the baseline visit.
- •22. Subjects who are taking any medication not allowed.
- •23. Subjects who received clozapine for 12 weeks, deposit antipsychotics for 4 weeks, or an inhibitor of monoamine oxidase during the 2 weeks prior to the baseline visit.
- •24. Subjects identified with medical history or hospitalization records of having used phencyclidine during the 30 days prior to the screening visit.
- •25. Subjects that require treatment with drugs that have been observed to prolong the QT interval.
- •26. Subjects who received a research drug during the 4 weeks prior to the baseline visit.
- •27. Subjects who received ziprasidone in a previous clinical study.
- •28. Subjects who were identified with ziprasidone allergy.
- •29. Subjects with a history of induced antipsychotic EPS that do not respond to antiparkinson medication.
- •30. Subjects with a previous episode of neuroleptic malignant syndrome or a previous hypersensitivity to antipsychotic agents.
- •31. Subjects with a history of no response to ziprasidone, after a period of adequate treatment, with doses between 120-160 mg per day.
研究者
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