AVP-786 作为对抗抑郁治疗反应不足的重度抑郁症患者辅助治疗的疗效、安全性和耐受性研究
一项 2 期、多中心、随机、双盲、安慰剂对照研究，旨在评估 AVP-786（氘修饰的氢溴酸右美沙芬/硫酸奎尼丁）作为重度抑郁症辅助治疗的疗效、安全性和耐受性抗抑郁治疗反应不足
这项为期 10 周的研究旨在评估 AVP 786 作为辅助疗法与安慰剂相比对标准抗抑郁药治疗反应不足的重度抑郁症 (MDD) 患者的疗效、安全性和耐受性。
本研究的第二个目的是评估 AVP-786 的药代动力学 (PK) 以及与药效学效应的潜在相关性。
研究概览
详细说明
据估计，美国大约 30 个招募中心将有多达大约 200 名患者参与这项研究。
符合本研究条件的患者必须患有精神障碍诊断和统计手册 (DSM-IV-TR) 标准定义的 MDD，并且对标准抗抑郁治疗反应不足。
这是一项为期 10 周的多中心、随机、双盲、安慰剂对照研究。
按照用于评估纳入和排除标准的筛选程序，符合条件的患者将被随机分配到研究中。 研究药物将在整个治疗期间每天口服两次 (BID)（早上 1 粒胶囊，晚上 1 粒胶囊，间隔约 12 小时）。
研究类型
介入性
注册 (实际的)
206
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Alabama
-
Birmingham、Alabama、美国、35294
-
Birmingham、Alabama、美国、35213
-
-
California
-
Bellflower、California、美国、90706
-
Costa Mesa、California、美国、92626
-
Garden Grove、California、美国、92845
-
Lomita、California、美国、90717
-
Oceanside、California、美国、92056
-
Riverside、California、美国、92506
-
Santa Ana、California、美国、92706
-
Sherman Oaks、California、美国、91403
-
-
Colorado
-
Denver、Colorado、美国、80239
-
-
Florida
-
Bradenton、Florida、美国、34201
-
Jacksonville、Florida、美国、32256
-
Miami、Florida、美国、33155
-
Orange City、Florida、美国、32763
-
Orlando、Florida、美国、32801
-
-
Georgia
-
Decatur、Georgia、美国、30030
-
-
Illinois
-
Hoffman Estates、Illinois、美国、60169
-
-
Indiana
-
Valparaiso、Indiana、美国、46383
-
-
Maryland
-
Baltimore、Maryland、美国、21285
-
Glen Burnie、Maryland、美国、21061
-
-
Massachusetts
-
Boston、Massachusetts、美国、02131
-
-
New York
-
Brooklyn、New York、美国、11241
-
New York、New York、美国、10003
-
Staten Island、New York、美国、10312
-
-
Ohio
-
Garfield Heights、Ohio、美国、44125
-
-
Oklahoma
-
Oklahoma City、Oklahoma、美国、73112
-
Oklahoma City、Oklahoma、美国、73103
-
Tulsa、Oklahoma、美国、74101
-
-
Pennsylvania
-
Philadelphia、Pennsylvania、美国、19104
-
Philadelphia、Pennsylvania、美国、19139
-
-
Utah
-
Murray、Utah、美国、84123
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
14年 及以上 (成人、年长者)
接受健康志愿者
不
描述
纳入标准：
- 持续时间≤ 24 个月的重度抑郁发作的临床诊断
- HAM-D17 评分≥20。
- 记录在筛选和基线访问之间 QIDS-SR16 分数没有显着（25% 或更大）变化。
- 在当前抑郁发作期间，患者被认为对至少 1 个但不超过 3 个充分的抗抑郁试验反应不足（症状减少小于 50%）。
- 患者必须接受足量抗抑郁药的持续治疗。
- 体重指数 (BMI) 为 18-35 公斤/平方米。
排除标准：
- 重症肌无力史。
有心血管问题，例如：
- 完全性心脏传导阻滞史、针对心率 (QTc) 延长校正的 QT 间期或尖端扭转型室性心动过速。
- QTc 使用 Fridericia 公式 (QTcF) 在筛选时基于筛选访视时的中央审查，男性 > 450 毫秒，女性 > 470 毫秒，除非由于心室起搏。
- 任何先天性 QT 间期延长综合征的家族史。
- 已知对 DM、Q、阿片类药物（可待因等）或研究药物的任何其他成分过敏/不耐受。
存在当前的自杀风险，如以下任何一项所示：
- 研究者判断受试者可能有自杀的风险。
- 如果最近的事件发生在过去 12 个月内，则受试者对基线 C-SSRS 的问题 4 或问题 5 的评分为“是”。
- 受试者在过去 6 个月内曾企图自杀
- 存在任何其他当前 DSM-IV-TR 轴 I 障碍，但以下情况除外：广泛性焦虑症 (GAD: 300.02)、社交焦虑症 (300.23)、 心境恶劣障碍 (300.4)，或特定恐惧症 (300.29)。 患有合并症 GAD、社交焦虑障碍或特定恐惧症的患者如果合并症在临床上不稳定，或者在筛选前 6 个月内一直是治疗的主要焦点，则不符合资格
轴 I 诊断：
- 谵妄、痴呆、遗忘症或其他认知障碍；
- 精神分裂症或其他精神障碍，基于 M.I.N.I.；
- 双相 I 型或 II 型障碍，基于 M.I.N.I.
- 边缘性、反社会、偏执、分裂样、分裂型或表演型人格障碍的具有临床意义的轴 II (DSM-IV-TR) 诊断。
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较：安慰剂
|
在 10 周内每天服用两次安慰剂胶囊
|
|
实验性的：AVP-786
|
AVP-786 胶囊在 10 周内每天给药两次
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Montgomery-Ǻsberg Depression Rating Scale (MADRS) total score
大体时间：Visit 5 (Day 70) Week 10
|
The MADRS consists of 10 items, each rated based on the structured interview.
The dimensions assessed in the MADRS are as follows: 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10.
Suicidal thoughts.
Each item is rated on a scale from 0 to 6.
The MADRS total score is the sum of the scores for the 10 dimensions and can range from 0 to 60, with higher scores indicating a higher severity of depression.
|
Visit 5 (Day 70) Week 10
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
17-item Hamilton Rating Scale for Depression (HAM-D17)
大体时间：Visit 5 (Day 70) Week 10
|
The HAM-D is a clinician-rated scale that evaluates the level of depression.
The HAM-D consists of 17 items (with scale in parentheses) such as Depressed Mood (0-4), Guilt (0-4), Suicide (0-4), Insomnia, initial (0-2), Insomnia, middle (0-2), Insomnia, late (0-2), Work and Interests (0-4), Psychomotor Retardation (0-4), Psychomotor Agitation (0-4), Anxiety, psychic (0-4), Anxiety, somatic (0-4), Gastrointestinal Symptoms (0-2), Somatic Symptoms, general (0-2), Sexual Interest (0-2), Hypochondriasis (0-4), Insight (0-2), and Weight Loss (0-2).
Summed subscales are combined to compute a total score.
Total score ranges from 0 to 52, with a higher score indicating worse condition.
|
Visit 5 (Day 70) Week 10
|
|
Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH ATRQ)
大体时间：Visit 5 (Day 70) Week 10
|
The MGH ATRQ is given in this study to assess treatment resistance in depression.
Participants are to provide information on the questionnaire about the dose level and duration for each medication that has been taken during their current episode/stage of depression.
Participants are also to provide the medication that helped them the most and answer a question about the degree of improvement.
|
Visit 5 (Day 70) Week 10
|
|
16-item Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR16)
大体时间：Visit 5 (Day 70) Week 10
|
The 16-item Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR16) is a patient-reported questionnaire used to assess the severity of depressive symptoms over the previous 7 days.
The questionnaire assesses sleep, mood, appetite/weight, concentration, self-perception, suicidal thoughts, interest, energy, and psychomotor changes.
Each item is scored from 0 to 3, with higher scores indicating greater symptom severity.
The total score is calculated using a standard algorithm that sums the highest-rated item within selected symptom domains and individual domain scores, resulting in a total score ranging from 0 to 27, with higher scores indicating more severe depressive symptoms.
|
Visit 5 (Day 70) Week 10
|
|
Sheehan Disability Scale (SDS)
大体时间：Visit 5 (Day 70) Week 10
|
The participant is to assess how disruptive their depression symptoms have been on a 0 to 10 scale, as shown below: 0 Not at all, 1 to 3 Mildly, 4 to 6 Moderately, 7 to 9 Markedly, 10 Extremely.
The 3 items will be summed to obtain a measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired).
Higher scores indicate worse conditions.
|
Visit 5 (Day 70) Week 10
|
|
Clinical Global Impression of Severity of Illness (CGI-S)
大体时间：Visit 5 (Day 70) Week 10
|
The CGI-S is clinician's assessment of the participant's illness at the time of the assessment.
The CGI-S is scored according to the following 7-point scale, with a higher score indicating a higher severity of illness (0 = not assessed): 1 = normal, not at all ill, 2 = borderline mentally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = extremely ill.
|
Visit 5 (Day 70) Week 10
|
|
Clinical Global Impression of Change (CGI-C)
大体时间：Visit 5 (Day 70) Week 10
|
The CGI-C is clinician's assessment of the participant's change in illness at the time of the assessment, using the following 7-point scale (0 = not assessed): 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse.
A lower score indicates an improvement in illness.
|
Visit 5 (Day 70) Week 10
|
|
EuroQOL 5 Dimension 5 Level (EQ-5D-5L)
大体时间：Visit 5 (Day 70) Week 10
|
The EQ-5D-5L, a scale used to measure quality of life, is divided into 2 parts, the descriptive system and the visual analog scale (VAS), reported as separate scores.
The descriptive system is divided into five categories: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
For each category, the participant selects the one statement that best describes their health on the day of assessment.
Each category is scored on a 5-point scale(1=no problems to 5=extreme problems or inability to perform the activity) [e.g., for mobility: 1 = no problems walking and 5 = unable to walk].
Missing values for a given category are imputed with a value of 9 and are excluded from the summary for that category.
Higher scores for each category= worse health condition.
The VAS is a 0 (worst health you can imagine) to 100 (best health you can imagine) vertical scale, where the participant places an X on the scale where they feel their health is today and then writes the number.
|
Visit 5 (Day 70) Week 10
|
|
Patient Global Impression of Change (PGIC)
大体时间：Visit 5 (Day 70) Week 10
|
The PGI-C asks the participant to rate their overall impression of change in their depression symptoms from the time of study entry to the present.
The PGI-C is scored on a 7-point scale, where 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.
Higher scores indicate worsening of depression symptoms.
|
Visit 5 (Day 70) Week 10
|
|
7-item Generalized Anxiety Disorder (GAD-7)
大体时间：Visit 5 (Day 70) Week 10
|
The GAD-7 is a self-reported questionnaire used to assess symptoms of generalized anxiety disorder.
It consists of 7 questions evaluating feelings of nervousness or anxiety, inability to stop or control worrying, excessive worrying, trouble relaxing, restlessness, irritability, and fear that something awful might happen.
Each item is scored on a 4-point scale, where 0 = not at all, 1 = several days, 2 = more than half the days, and 3 = nearly every day.
The scores for all seven items are summed to produce a total score ranging from 0 to 21, with higher scores indicating greater severity of anxiety symptoms.
|
Visit 5 (Day 70) Week 10
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2014年7月1日
初级完成 (实际的)
2016年2月1日
研究完成 (实际的)
2016年2月1日
研究注册日期
首次提交
2014年5月29日
首先提交符合 QC 标准的
2014年5月30日
首次发布 (估计的)
2014年6月3日
研究记录更新
最后更新发布 (实际的)
2026年7月13日
上次提交的符合 QC 标准的更新
2026年7月9日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 14-AVP-786-201
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal.
Small studies with less than 25 participants are excluded from data sharing.
IPD 共享时间框架
Data will be available after marketing approval in global markets or beginning 1-3 years following article publication.
There is no end date to the availability of the data.
IPD 共享访问标准
Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.