NL-OMON32293已完成4 期
International Study for the Prediction of Optimized Treatment - in Depression - iSPOT-D
Brain Resource Company0 个研究点目标入组 112 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 112
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •meet DSM-IV criteria for primary diagnosis of MDD (patients), HAMD score>16 (patients), age between 18-65, Dutch fluency (patients and healty controls) signed a written informed consent (patients and health controls)
排除标准
- •1) presence of bipolar disorder, psychosis or primary eating disorders (patients) or current or previous diagnosis of MDD or other Axis 1 disorder (healthy controls) 2) pregnancy and women of child bearing potential who are not taking a medically accepted form of contraception and are at risk of becoming pregnant during the study, 3) breastfeeding, 4) presence of contra-indication of usage of Escitalopram, Sertraline or Venlafaxine XR (patients) 5) usage of any antidepressant or CNS drug which can not be washed out prior to participation 6) use of any medication which is known to be contraindicated with Escitalopram, Sertraline, or Venlafaxine XR 7)evidence of either hyper or hypo-thyroidism within previous 3 months, 8) known medical condition, disease or neurological disorder which might, in the opinion of the investigator, interfere with the assessments to be made in the study or put subjects at increased risk when exposed to optimal doses of the drug treatment, 9) personal history of physical brain injury or blow to the head that resulted in loss of consciousness of greater than five minutes, 10) recent/current substance dependence in accordance with current ABS criteria in the past 6 months, 11) participation in an investigational study within four months of the baseline visit in which subjects have received an experimental drug/device that could affect the primary end points of this study, 12)subjects who, in the opininon of the investigator, have a severe impediment to vision, hearing and/or hand movement, which is likely to interfere wiht their ability to complete the testing batteries, 13) subjects who, in the opininon of the investigator, are unable and/or unlikely to comprehend and follow the study procedures and instructions.
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