EUCTR2006-004146-16-DE进行中（未招募）不适用
A multi-national, multi-center, double blind, placebo-controlled, parallel group, fixed dose efficacy and safety study of SR58611A 350 mg twice daily vs. placebo in adults with Major Depressive Disorder on concomitant treatment with escitalopram 10 mg/d - ALBERIO
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
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
- •Adult patients (ages 18 years to 65 years) with Major Depressive Disorder.
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion criteria related to study methodology
- •1. Is unable/unwilling to volunteer informed consent to participate in the study, or
- •2. Is unable/unwilling to participate in or follow the procedures required by the study
- •through the last scheduled visit, or
- •3. Following psychiatric evaluation, the patient does not have a diagnosis of Major
- •Depressive Disorder according to Diagnostic and Statistical Manual of Mental
- •Disorders (Fourth Edition) -- Text Revision (DSM-IV-TR) (3), or
- •4. Does not meet criteria for a recurrent Major Depressive Episode (MDE) according to
- •DSM-IV-TR and M.I.N.I. International Neuropsychiatric Interview (MINI) (4) for at
- •least 1 month but no more than 2 years, or
- •5. Does not present with a Montgomery-Asberg Depression Rating Scale (MADRS) (5)
- •total score =30, or
- •6. Patient has a psychiatric diagnosis that could interfere with evaluation of the
- •investigational product;
- •7. Patient is at immediate risk for suicidal behavior based on an unstructured clinical
- •interview; or has:
- •- A score of >5 on the suicidal thoughts item of the MADRS, or
- •- A score of 4 on the suicide item of the Hamilton Depression Rating Scale, or
- •- A current suicide risk score = 10 from module C of the MINI, or
- •8. Patient has taken, or requires, or is expected to require within 2 weeks of the date of randomization, concomitant treatment that may interfere with valid collection or interpretation of study data
- •9. Patient has been treated with electroconvulsive or other non-pharmacologic biological
- •therapy (e.g., phototherapy), or effective psychotherapy in the past 6 months, or
- •10. Patient presents with evidence (e.g., positive results from a urine drug screen,
- •observation, interview) during the screening period of illegal or covert drug use, or
- •11. During the screening period, patient presents with a current or past history, physical signs, clinical laboratory, or electrocardiogram (ECG) evidence of a clinically
- •significant or unstable medical, neurological, surgical, obstetrical or congenital
- •condition that may, in the Investigator’s medical judgment, interfere with valid
- •collection or interpretation of efficacy or safety data, or
- •12. Patient is at risk for clinical deterioration, anaphylaxis, a withdrawal syndrome,
- •residual effects, serotonin toxicity or drug interaction as a consequence of prior,
- •current, or abrupt discontinuation of pharmacologic treatment, or
- •13. Patient is pregnant (based on pregnancy test, history, or physical exam) or
- •breastfeeding, or likely to become pregnant during the course of the study, or
- •14. Patient is unwilling or unable to be tested for pregnancy (if pregnancy is a possibility during the study), or unwilling or unable to properly use an effective method of pregnancy prevention (e.g., hormonal contraception, intrauterine device, physical barrier plus spermicide).
- •Exclusion criteria related to escitalopram
- •15. Patient has been treated with escitalopram within the previous 6 months, or
- •16. Patient has a history of untoward reaction possibly related to prior treatment with escitalopram (e.g., history of serotonin toxicity) that may interfere with adherence
- •during the study, or
- •17. Patient with hypersensitivity to escitalopram or to any of the excipients (e.g.,
- •microcrystalline cellulose, colloidal anhydrous silica, talc, croscarmellose sodium,
- •magnesium stearate, hypromellose, Macrogol 400, titanium dioxide [E 171]), or
- •18. Patient requires, or is expected to require concomitant treatment with non-selective, irrevers
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