EUCTR2009-010902-13-GB进行中（未招募）1 期
Duloxetine versus Placebo in the Treatment of Elderly Patients with Generalized Anxiety Disorder - HMGF
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
- 288
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
入选标准
- •[1] Male and female outpatients at least 65 years old presenting with GAD based on the DSM-IV TR diagnostic criteria. The patient must suffer from a primary diagnosis of GAD and not from an adjustment disorder or anxiety disorder NOS. Symptoms of GAD should not be situational in nature. [2] Have a MMSE score of at least 24 at Visit 1. [3] Have a CGI-Severity score of =4 at Visit 1 and Visit 2. [4] Have a CAS score of =9, no item in the RDS may be >3, and the CAS score must be greater than the RDS at Visit 1. [5] Have a HADS anxiety subscale score of =10 at Visit 1.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •[8] Have any current DSM-IV TR Axis I diagnosis other than GAD, with the exception of comorbid social phobia or specific phobia. [9] The presence of an Axis II disorder, or history of antisocial behavior, or patients who, in the opinion of the investigator, are poor medical or psychiatric risks for study compliance. [10] Have organic mental disorder or mental retardation diagnosis. [11] Currently use benzodiazepine or have used benzodiazepine 14 days prior to Visit 2. [12] Are judged clinically to be at serious risk of harm to self or others. [15] Have a history of alcohol or any psychoactive substance abuse or dependence (as defined in the DSM-IV TR) within the past 6 months. [16] Excessively use caffeine, in the opinion of the investigator. [17] Have a positive UDS for any substances of abuse at Visit 1. [18] Have a serious medical illness, including any cardiovascular, hepatic, renal, respiratory, hematologic, endocrinologic, or neurologic disease, or clinically significant laboratory abnormality that is not stabilized or is anticipated to require hospitalization within 6 months, in the opinion of the investigator. Clinically significant laboratory abnormalities are those that, in the judgment of the investigator, indicate a serious medical problem. [19] Have any acute liver injury (such as hepatitis) or severe cirrhosis (Child-Pugh Class C). [20] Have an abnormal thyroid-stimulating hormone (TSH) concentrations (outside the reference range of the performing laboratory). [21] Have initiated psychotherapy or changed intensity of psychotherapy or other non-drug therapies (such as acupuncture or hypnosis) within 6 weeks prior to enrollment or at any time during the study. [22] Have taken any excluded medication within 7 days prior to Visit 2. [23] Have been treated with a monoamine oxidase inhibitor (MAOI) or fluoxetine within 30 days of Visit 2 or potentially need to use an MAOI during the study or within 5 days of discontinuation of study drug. [24] Exhibit a lack of response of the current episode of GAD to 2 or more adequate trials of antidepressants, benzodiazepines, or other anxiolytics at a clinically appropriate dose for a minimum of 4 weeks. [25] Have a history of severe allergies, hypersensitivity to duloxetine or to any of the inactive ingredients; multiple adverse drug reactions; transcranial magnetic stimulation (TMS); history of seizures; or history of psychosurgery or electroconvulsive therapy (ECT) within 12 months. [26] Have discontinued hormone replacement therapy within the previous 3 months. [29] Have uncontrolled narrow-angle glaucoma.
研究者
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