EUCTR2012-005271-14-RO进行中（未招募）不适用
A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF LOW-DOSE LURASIDONE IN ACUTELY PSYCHOTIC SUBJECTS WITH SCHIZOPHRENIA
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 400
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
- •Subject is = 18 and = 75 years of age, and meets DSM-IV-TR criteria for a primary diagnosis of schizophrenia [including disorganized (295.10), paranoid (295.30), undifferentiated (295.90) subtypes] as established by clinical interview (using the DSM-IV-TR as a reference and confirmed by the SCID-CT). The duration of the subject’s illness whether treated or untreated must be = 6 months. Subject has a PANSS total score = 80 and PANSS subscale score = 4 (moderate) on 2 or more of the following PANSS subscale items: delusions, conceptual disorganization, hallucinations, and unusual thought content at screening and baseline and a CGI-S score of = 4 at screening and baseline. Subject has an acute exacerbation of psychotic symptoms (no longer than 2 months) and marked deterioration of function from baseline (by history) or subject has been hospitalized for the purpose of treating an acute psychotic exacerbation for 2 consecutive weeks or less immediately before screening.
- •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 380
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Diagnosis of a DSM-IV Axis I or Axis II diagnosis, other than schizophrenia, that has been the primary focus of treatment within 3 months of screening. Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
研究者
相似试验
已完成
不适用
A DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED STUDY IN EUROPE / LATIN AMERICA, CANADA TO EVALUATE THE EFFECT OF TOLTERODINE FOR PROLONGED RELEASE ON NICTURIA IN PATIENTS WITH HYPERACTIVE BLADDER SYMPTOMS (VHA)PER-047-02PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,
进行中（未招募）
1 期
Study Assessing the Long-term Effect of Dupilumab on Prevention of Lung Function Decline in Adult Patients with Uncontrolled Moderate to Severe AsthmaMedDRA version: 20.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersAsthmaEUCTR2021-003903-16-SKSanofi-aventis Recherche & Développement5,200
进行中（未招募）
1 期
Study Assessing the Long-term Effect of Dupilumab on Prevention of Lung Function Decline in Adult Patients with Uncontrolled Moderate to Severe AsthmaAsthmaEUCTR2021-003903-16-GRSanofi-aventis Recherche & Développement3,900
进行中（未招募）
1 期
Study Assessing the Long-term Effect of Dupilumab on Prevention of Lung Function Decline in Adult Patients with Uncontrolled Moderate to Severe AsthmaAsthmaMedDRA version: 20.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2021-003903-16-IESanofi-aventis Recherche & Développement3,900
进行中（未招募）
1 期
Study Assessing the Long-term Effect of Dupilumab on Prevention of Lung Function Decline in Adult Patients with Uncontrolled Moderate to Severe AsthmaAsthmaMedDRA version: 20.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2021-003903-16-BGSanofi-aventis Recherche & Développement3,900