NCT02805439已完成2 期
Efficacy and Safety of S 47445 Versus Placebo as Adjunctive Treatment of Major Depressive Disorder in Patients With an Inadequate Response to Antidepressant Therapy: A Randomised, Double-blind, Placebo Controlled International, Multicentre Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 53
- 主要终点
- Hamilton Depression Rating Scale (HAM-D) total score expressed as change from baseline value
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of S47445 versus placebo as adjunctive treatment of Major Depressive Disorder in patients with an inadequate response to antidepressant therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients
- •Fulfilling DSM-5 criteria for Major Depressive Disorder confirmed by the brief structured interview M.I.N.I. (single or recurrent episode, current episode ≤ 12 months, current depressive episode of moderate or severe intensity, with or without anxious distress, with or without melancholic features, without mixed features or atypical features, without seasonal pattern, without psychotic features, without catatonic features, without peripartum onset for the current episode)
- •Patients treated for the current depressive episode with an antidepressant treatment with SSRI (fluoxetine, citalopram, paroxetine, escitalopram or sertraline) given in monotherapy at recommended dose for at least 6 weeks and no more than 4 months and with a stable dosage for at least 3 weeks
- •HAM-D total score ≥ 20
- •Clinical Global Impression Severity of illness (item 1): 6 ≥ CGI-S ≥ 4
- •Antidepressant Treatment Response Questionnaire (ATQR) < 50% for the current SSRI
- •Absence of any abnormalities likely to interfere with the conduct of the study (ECG, vital signs, laboratory tests, medical history)
排除标准
- •Depressive episode of mild intensity according to DSM-5 criteria
- •All types of depressive episodes other than those occurring in a Major Depressive Disorder (Persistent Depressive Disorder (Dysthymia) according to DSM-5 criteria, including persistent depressive disorder with intermittent or persistent major depressive episode according to DSM-5, Premenstrual Dysphoric Disorder, Substance Induced Depressive Disorder, Depressive Disorder due to another Medical Condition, Other Specified or Unspecified Depressive Disorder, Bipolar Disorder I or II, depressed episode, Schizoaffective Disorder (Depressive or Bipolar type))
- •Depression onset within 12 months after a stroke
- •Suicidal risk defined as a score > 3 on the item 3 of the HAM-D scale or in the investigator's opinion
- •Lactose intolerance
- •Patients with hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •Resistant depression for the current episode (patients who have not responded to 1 previous antidepressant treatment before the SSRI taken at an appropriate dose)
- •Current panic disorder
- •Obsessive compulsive disorder
- •Current post traumatic stress disorder, current acute stress disorder
- •Current or past psychotic disorder
- •Any severe personality features
研究组 & 干预措施
S47445 15mg
Experimental
干预措施: S47445 15mg (Drug)
S47445 50mg
Experimental
干预措施: S47445 50mg (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Hamilton Depression Rating Scale (HAM-D) total score expressed as change from baseline value
时间窗: 8 weeks of treatment
次要结局
- Adverse Events(through study completion (an average of 12 weeks))
- Laboratory tests (haematology and biochemistry)(at week 4 and week 8)
- HAM-D total score(at week 0, week 2, week 4, week 6 and week 8)
- Body Weight(at week 4 and week 8)
- BMI(at week 4 and week 8)
- Vital signs (standing and supine Systolic and Diastolic Blood Pressure, heart rate)(at week 0, week 2, week 4, week 6 and week 8)
- Response to treatment defined by HAM-D total score decrease from baseline ≥ 50%(at week 0, week 2, week 4, week 6 and week 8)
- Sheehan Disability Scale (SDS) scores (Work, social and family life)(at week 0, week 2, week 4, week 6 and week 8)
- Clinical Global Impression scale (CGI), item 1 (Severity of depression) and item 2 (global Improvement) scores, response to treatment (CGI item 2 = 1 or 2)(CGI item 1 at week 0, week 2, week 4, week 6 and week 8 and item 2 at week 2, week 4, week 6 and week 8)
- Hospital Anxiety and Depression Scale (HAD), Anxiety and Depression sub-scores(at week 0, week 2, week 4, week 6 and week 8)
- Columbia-Suicide Severity Rating Scale (C-SSRS)(at week 0, week 2, week 4, week 6 and week 8)
- 12-lead ECG(at week 4 and week 8)
研究者
研究点 (53)
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