AN 8-WEEK, PLACEBO-CONTROLLED, DOUBLE-BLIND, RANDOMIZED, FIXED-DOSE EFFICACY AND SAFETY TRIAL OF ASENAPINE IN ADOLESCENT SUBJECTS WITH SCHIZOPHRENIA

SCHERING PLOUGH RESEARCH INSTITUTE,0 个研究点目标入组 0 人开始时间: 2010年9月10日最近更新: 2023年9月4日

适应症

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•Each participant must have schizophrenia, diagnosed and confirmed by board-eligible or board certified psychiatrists with at least two years of specialization in pediatric/adolescent psychiatric medicine.
•Each participant must be ≥12 years of age and <18 years of age.
•Each participant must have a minimum PANSS total score of 80 at Screening and Baseline.
•Each participant must have a score of at least 4 (moderate) on two or more of the five items in the positive subscale of the PANSS (delusions, conceptual disorganization, hallucinatory behavior, grandiosity, suspiciousness/ persecution) at Screening and Baseline.
•Each participant must have a CGI-S scale score of ≥4 at Screening and Baseline.
•Each participant must taper off all prohibited psychotropic medications (including antipsychotics, antidepressants, and mood stabilizers) prior to Baseline.
•Each participant must agree not to begin formal, structured psychotherapy during the trial.

•A participant must not have a diagnosis of schizoaffective disorder; schizophrenia of residual subtype; schizophrenia of catatonic subtype, or schizophrenia with continuous, single episode in partial remission, or single episode in full remission course specifiers.
•A participant must not have a primary Axis I diagnosis other than schizophrenia and must not have a comorbid Axis I diagnosis that is primarily responsible for current symptoms and functional impairment.
•A participant must not have a known or suspected diagnosis of mental retardation or organic brain disorder.
•A participant must not currently (within the past 6 months) meet the Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revision (DSM-IV-TR^TM) criteria for substance abuse or dependence (excluding nicotine).
•A participant must not have a diagnosis of psychotic disorder or a behavioral disturbance thought to be substance induced or due to substance abuse.
•A participant must not be at imminent risk of self-harm or harm to others, in the investigator´s opinion based on clinical interview and responses provided on the Columbia Suicide Severity Rating Scale (C-SSRS).

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