EUCTR2008-002319-42-SE进行中（未招募）1 期
Comparison of Two Different Treatment Strategies in Patients with Major Depressive Disorder Not Exhibiting Improvement on Escitalopram Treatment: Early vs. Delayed Intervention Strategy - HMGD
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
- 1,160
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 or female outpatients of at least 18 years of age who meet criteria for MDD, single or recurrent episode according to the DSM-IV®-TR disease diagnostic criteria.
- •[2] Patients (receiving or not antidepressant treatment) who, based on investigator criteria, initiate treatment with escitalopram or change their current AD treatment to escitalopram for this current MDD episode, at Visit 1.
- •[3] Must have a baseline score of =19 on the HAM-D17 at visit 1.
- •[4] Must have a baseline score of = 4 in the Clinical Global Impression- Severity (CGI-S) at visit 1.
- •[5] Have a level of understanding sufficient to provide ICD, and to communicate with the investigators and site personnel.
- •[6] Are judged to be reliable and agree to keep all appointments for clinic visits and procedures required by the protocol.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •[7] Have any current primary Axis I disorder other than MDD
- •[8] Have a diagnosis of dementia, Alzheimer’s disease, or organic brain syndrome; or who are cognitively impaired or who have language problems that prevent them from understanding and/or providing valid answers to the rating scale contents.
- •[9] Concomitant participation in other studies with investigational or marketed products.
- •[10] Are not expected to be able to be monitored throughout the entire study period for reasons unrelated to their illness
- •[11] Are demonstrating a response or demonstrated a response to the AD treatment for the current depression episode previous to baseline visit
- •[12] Are investigator site personnel directly affiliated with this study and/or their immediate families
- •[13] Are employed by Lilly or Boehringer Ingelheim (BI)
- •[14] Women of childbearing potential who are not using a medically accepted means of contraception. Women who are pregnant or breast-feeding may not participate in the study.
- •[15] Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
- •[16] Are judged to be at serious suicidal risk in the opinion of the investigator, and/or if the patient’s baseline (visit 1) HAMD17 scores on item 3 suicide are ?3.
- •[17] Have been treated with a MAOI within 14 days prior to visit 1 or potential need to use an MAOI during the study or within 5 days after discontinuation of study drug.
- •[18] Require initiation or discontinuation of psychotherapy within 6 weeks prior to enrollment
- •[19] Have any contraindication for the use of duloxetine or escitalopram based on Duloxetine and Escitalopram SPC.
- •[20] Have a history of lack of response to duloxetine or escitalopram at a clinically appropriate dose for a minimum of 4 weeks, or have previously completed or withdrawn from this study or any other study investigating duloxetine or escitalopram.
- •[21] Have any previous diagnosis of psychotic disorders.
- •[22] Have DSM-IV-defined history of substance abuse or dependence within the past year, excluding nicotine and caffeine
- •[23] Have serious or unstable cardiovascular, hepatic, renal, respiratory or hematological illness; symptomatic peripheral vascular disease; or other medical or psychological conditions that, in the opinion of the investigator, would compromise participation or be likely to require hospitalization during the course of the study.
- •[24] Have had ECT or Transcranial Magnetic Stimulation within the past year
研究者
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