EUCTR2014-000456-29-CZ进行中（未招募）1 期
EFFICACY AND SAFETY OF INHALED LOXAPINE COMPARED WITH IM ANTIPSYCHOTIC IN ACUTELY AGITATED PATIENTS WITH SCHIZOPHRENIA OR BIPOLAR DISORDER - N/A
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 468
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
- •1. Male and female patients between the ages of 18 to 65 years, inclusive.
- •2. Patients who met Diagnostic and Statistical Manual of Mental Disorders (DSM-5 criteria for schizophrenia or bipolar disorder I.
- •3. Patients judged to be clinically agitated at baseline with a value of = 4 out of the 7 items on the CGI S scale.
- •4. Written informed consent from patients with documented adequate consent capacity per the Investigator’s judgement.
- •5. Patients in good general health prior to study participation as judged by the Investigator and stated in the patient’s record.
- •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 468
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patients with agitation caused primarily by acute intoxication (as per Investigator’s judgment).
- •2. Patients with acute alcohol or psychoactive drugs intoxication/withdrawal symptoms incompatible with their participation in the study as judged by the Investigator.
- •3. Patients judged to be at serious risk for suicide as per the Investigator’s judgement.
- •4. Patients treated with benzodiazepines or other hypnotics or oral or short-acting IM antipsychotics within 1 hour prior to study drug administration (however, those patients may be subsequently reassessed for inclusion).
- •5.Patients with a history of allergy or intolerance to loxapine or amoxapine and/or aripiprazole.
- •6. Female patients of childbearing potential who have a positive urine pregnancy test at screening or breastfeeding or inpatients who previously had a positive serum pregnancy test upon admission.
- •7. Patients with previous laboratory or electrocardiogram abnormalities considered relevant by the Investigator that may have clinical implications for the patient's participation in the study.
- •8. Patients with significant hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease and congestive heart failure), endocrinologic, neurologic or hematologic disease.
- •9. Patients with acute respiratory signs/symptoms (e.g., wheezing) or with active airways disease (such as patients with asthma or chronic obstructive pulmonary disease).
- •10. Patients who received an investigational drug within 30 days prior to screening.
- •11. Patients who are considered by the Investigator, for any reason, to be unsuitable candidates for receiving inhaled loxapine, or are likely to be unable to use the inhalation device.
研究者
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