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临床试验/CTRI/2010/091/000423
CTRI/2010/091/000423已完成3 期

AN OPEN LABEL, RANDOMIZED, PARALLEL GROUP, PROSPECTIVE, MULTICENTER CLINICAL TRIAL OF ASENAPINE TO EVALUATE ITS SAFETY AND EFFICACY IN ADULT PATIENTS WITH ACUTE EXACERBATION OF SCHIZOPHRENIA

Intas Pharmaceuticals Limited0 个研究点目标入组 280 人开始时间: 待定最近更新:
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试验速览

阶段
3 期
状态
已完成
入组人数
280
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

入排标准

入选标准

  • •1)Patients of either sex between 18 and 65 years of age, with acute exacerbation of schizophrenia as per DSM-IV-TR (In case of female with child bearing potential: surgically sterile or using a medically accepted means of contraception with negative serum pregnancy test)
  • •2)Patient or his/her legally acceptable representative willing to provide written informed consent
  • •3)Patient must have a legally acceptable representative who could provide support to the patient to ensure compliance with study treatment and study visits
  • •4)Patients must have a current acute exacerbation of Schizophrenia as evidenced by a Positive and Negative Syndrome Scale (PANSS) score of greater or equal to 60 at both screening and baseline, a Clinical Global Impression of Severity (CGI-S) score of greater or equal to 4 (moderately ill) at baseline, and a PANSS items scores of greater or equal to 4 on at least two of the five core positive symptoms items (delusions, conceptual disorganization, hallucinatory behavior, grandiosity, and suspiciousness /persecution) at screening and baseline.
  • •5)Patients must have responded previously to an antipsychotic drug other than clozapine, if they had been treated previously with antipsychotic medication

排除标准

  • •1)Baseline total PANSS score < 80 percentage of the screening PANSS score
  • •2)Pregnancy and lactation
  • •3)Diagnosis of residual subtype of schizophrenia or shizoaffective disorder (as per DSM-IV-TR)
  • •4)Primary psychiatric diagnosis other than schizophrenia (as per DSM-IV-TR)
  • •5)A score of > 2 (mild) on any item of the Abnormal Involuntary Movement Scale (AIMS) at screening
  • •6)Parkinson?s disease
  • •7)Hyperglycemia (Random blood sugar > or = 140 mg/dL) or diabetes mellitus
  • •8)History of signs and symptoms of orthostatic hypotension i.e. syncope
  • •9)History of drug induced leucopenia/neutropenia/agranulocytosis
  • •10)Cardiac arrhythmia, QT prolongation or conditions predisposing for prolongation of QT interval i.e. bradycardia, dehydration or hypokalemia
  • •11)Hyperprolactinemia (serum prolactin level >30 ng/mL) or disease conditions augmented by elevated serum prolactin levels, e.g., breast cancer or pheochromocytoma
  • •12)History of suicidal tendency
  • •13)History of seizure disorder
  • •14)History of alcohol or drug abuse
  • •15)Hepatic function impairment (SGPT or SGOT level > or = 2.5 times upper normal limit) renal function impairment (serum creatinine > or = 1.5 times upper normal limit)
  • •16)Ongoing treatment with prohibited medications, viz. other antipsychotic drugs, other psychotropic medication, dopaminergic agonists, drugs prolonging QTc interval, drugs causing bradycardia, drugs causing electrolyte imbalance, &#945;1-antagonists, strong CYP1A2 inhibitors or any investigational drug.
  • •17)Deemed inappropriate for enrollment by investigating physician due to other reasons

研究者

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