EUCTR2008-001718-26-SK进行中（未招募）不适用
An eight-week, multicenter, randomized, double-blind, placebo-controlled dose-finding study, with escitalopram (10mg daily) as active control, to evaluate the efficacy, safety and tolerability of three fixed doses of SSR411298 (10, 50, or 200mg daily) in elderly patients with Major Depressive Disorder
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
- •1. Male or female outpatient =60 years of age.
- •2. Diagnosis of major depressive disorder (MDD)
- •defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria
- •confirmed by the Mini International Neuropsychiatric Interview (MINI)
- •recurrent episode for at least one month prior to Visit 1
- •episode may be isolated or superimposed on dysthymic disorder and may meet criteria for atypical or melancholic features
- •may also meet criteria for anxiety disorder comorbid disorders (such as panic disorder with or without agoraphobia, social phobia or obsessive-compulsive disorder), provided that depression is the predominant disorder in terms of severity and subjective distress.
- •3. Given written informed consent.
- •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
- •-Exclusion criteria related to study methodology
- •1. Unable to comply with study protocol requirements.
- •2. HAM-D total score <16 at screening Visit 1 (Day -7) or baseline Visit 2 (Day -1)
- •3. Montgomery-Asberg Depression Rating Scale (MADRS) total score <22 at
- •screening Visit 1 (Day -7) or baseline Visit 2 (Day -1).
- •4. Mini-Mental State Examination (MMSE) < 23.
- •5. Significant suicide risk:
- •score of >5 on the suicidal thoughts item of the MADRS (item 10) at screening Visit 1
- •(Day -7) or baseline Visit 2 (Day -1)
- •or score of >3 on the suicide item (item 3) of the HAM-D at screening Visit 1 (Day -7)
- •or baseline Visit 2 (Day -1);
- •or a current suicide risk score =10 from Module C (suicidality) of the MINI.
- •6. History of a suicide attempt within the past 2 years.
- •7. Duration of the current depressive episode is greater than 2 years.
- •8. Current depressive episode has been diagnosed with psychotic features, catatonic
- •features, or seasonal pattern, or is secondary to a general medical condition (DSM-IV-TR 293.83).
- •9. History or presence of bipolar disorder or psychotic disorder, according to the item D and L of the MINI.
- •10. Post-traumatic stress disorders, anorexia nervosa and bulimia nervosa within the past 6 months, according to the items I, M and N of the MINI.
- •11. Meets DSM-IV-TR criteria for Antisocial Personality Disorder or Borderline
- •Personality Disorder.
- •12. Alcohol dependence or abuse or substance dependence or abuse in the past 12 months, according to the MINI, except nicotine or caffeine dependence.
- •13. Used the following prior to entry into the Randomized Treatment Phase:
- •a) Any monoamine oxidase inhibitors (MAOIs) within the past 2 weeks,
- •b) Any other antidepressant, antipsychotic, anxiolytic, sedative-hypnotic, or mood
- •stabilizer (lithium, anticonvulsants) within the past 7 days, except permitted
- •concomitant medications as defined in Section 3.
- •14. Prohibited concomitant treatments as defined in Section 3.
- •15. Treatment with electroconvulsive therapy (ECT) within the past 1 year.
- •16. Initiated, stopped, or changed frequency and/or nature of psychotherapy within the past 6 weeks.
- •17. Tested positive for any illicit drug included in the urine drug screen at Visit 1 (Day-7).
- •18. Abnormal thyroid function (ie, out of range TSH blood level at Visit 1) unless patients are receiving thyroid replacement therapy at a stable dose for the past 3 months and/or are considered clinically euthyroid.
- •19. Severe progressive or unstable cardiovascular, renal, hepatic, respiratory,
- •hematological, endocrinological, neurological, or other somatic disease that, according to the Investigator’s judgment, might interfere with the evaluation of study medication.
- •20. Significantly abnormal hepatic clinical laboratories: ALT, AST, or GGT >3x ULN; Tbili >ULN).
- •21. Participation in a clinical trial of an experimental therapy within the past 30 days or concomitant use of any FAAH inhibitor.
- •-Exclusion criteria related to escitalopram
- •21. Clinical history of non-response (4-week treatment at therapeutic dose) or intolerance to escitalopram or citalopram.
- •22. Hypersensitivity to escitalopram or citalopram or any of the inactive ingredients of the formulation.
- •-Exclusion criteria related to SSR411298
- •23. Using CYP3A strong inhibitors and inducers within the past 7 days.
- •24. Females who are not at least one year post-menopausal. (Post-menopausal is defined as the time after which a woman has experienced twelve consecutive months of amenorrhea, and menopausal s
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