CTRI/2014/04/004521已完成3 期
An Active-Control, Open label, Comparative, Randomized, 3-arm, Parallel group, Multicenter, Phase-III Clinical Study to evaluate the Efficacy and Safety of two doses of Lurasidone when compared with Quetiapine in newly diagnosed patients of Acute Schizophrenia.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
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. Male or female patients between 18 and 65 years (inclusive).
- •2. Patient meets DSM-IV criteria for primary diagnosis of Schizophrenia as established by clinical interview using M.I.N.I. (Mini International Neuropsychiatric Interview) diagnostic interview.
- •3. Patient is newly diagnosed with acute schizophrenia.
- •4. Patient has a PANSS total score >= 75 at the time of screening.
- •5. Patient has a score >= 4 (moderate) on 2 or more of the following PANSS items: Delusions, Conceptual disorganization, Hallucinations and Suspiciousness/persecution.
- •6. Patient has a score >= 4 on the CGI-S at screening.
- •7. Female patients of child bearing potential should have negative Urine Pregnancy Test (UPT) at the time of screening.
- •8. Patient or patientâ??s legally acceptable representative willing to sign the Informed Consent Document.
- •9.Patient willing and able to participate in all aspects of the core study, including use of oral medication, completion of subjective evaluations, and compliance with protocol requirements
排除标准
- •1. Elderly patients with dementia-related psychosis.
- •2. Diagnosis of mental retardation or other cognitive disorder
- •3. Any other Axis I psychiatric diagnosis.
- •4. Patient is currently on any anti-psychotic drug therapy.
- •5. Patient is considered by the investigator to be at imminent risk of suicide or injury to self, others or property.
- •6. Clinically significant suicidal or homicidal behavior or attempts within past 6 months.
- •7. Female patient has a positive pregnancy test at screening, is pregnant or lactating, or is planning to become pregnant during the study period.
- •8. Patient has received clozapine for refractory psychosis and/or patient has been treated with clozapine (for any reason) within 4 months of randomization.
- •9. Patient has received treatment with mood stabilizers or antidepressants within 1 week, fluexine hydrochloride at any time within 1 month or a monoamine oxidase (MAO) inhibitor with 3 weeks of randomization.
- •10. Presence of abnormal ECG parameters or significant cardiac disease, including uncompensated congestive heart failure, myocardial infarction within the past 6 months or known history of congenital long QT syndrome.
- •11. Patient requires treatment with a drug that prolongs the QT interval corrected for individual heart rate (QTc interval).
- •12. History of Neuroleptic Malignant Syndrome (NMS).
- •13. History of Orthostatic Hypotension and Syncope.
- •14. History of Diabetes Mellitus.
- •15. Patient has a history of hyperprolactinemia (prolactin concentration >100ng/mL at screening) or pituitary adenoma.
- •16. Patient has a history of leukopenia, neutropenia and/or agranulocytosis.
- •17. Patients who are currently or who will require treatment with strong CYP3A4 inhibitors (e.g., ketoconazole) or strong CYP3A4 inducers (e.g., rifampin) during the study.
- •18. Patients who have received or are currently on depot neuroleptics.
- •19. Any significant systemic disease, endocrine or metabolic abnormalities.
- •20. Alcohol or substance dependence within the past 12 months or abuse within the past 3 months.
- •21. Known hypersensitivity to any drug that will be administered during the study.
- •22. Inability to comply with the protocol requirements.
- •23. Participation in any other clinical trial within 3 months of registering in this trial.
研究者
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