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正在招募II 期编号 NCT04539951

Pragmatic Trial of Obsessive-compulsive Disorder

报名条件(概要)

  • 年龄:18 Years – 65 Years
  • 性别:不限
  • 健康志愿者:不接受

完整入排标准请以官方页面为准。

开展国家/地区

China

药品与企业信息

All included participants will receive sertraline, initially at 50mg/d, with a weekly 50mg/d further increase, to the maximum recommended dosage (200mg/d) or to the maximum tolerated dosage (less than 200mg/d). Patients will be on their maximum dose by week 4, so allowing an assessment of response at 12 weeks

In experimental phase II, the patients in this group will remain on sertraline (higher dosage): where sertraline 200mg has been tolerated, dosage will be increased by 50mg fortnightly to a maximal dose of 300mg/d or to the maximum tolerable dose (less than 300mg/d).

Fluvoxamine will be initiated at a dose of 50mg/d, increasing quickly to a maximal dose of 300mg/d or the maximum tolerated dose by week 4.

venlafaxine will be initiated at 75mg/d, increasingly weekly by 75mg/day, to a maximal dose of 300 mg/d or the maximum tolerated dose.

Augment with Memantine药物

Sertraline will be augmented with memantine initially at 5mg/d, and increasing by 5mg/d weekly to a maximal dose of 20mg/d (10mg twice daily) or the maximum tolerated dose

Augment with Aripiprazole药物

Sertraline will be augmented with aripiprazole, initially at 5mg/d, and increasing by 5mg/d weekly to a maximal dose of 20mg/d or the maximum tolerated dose

研发企业

Shanghai Mental Health Center研究机构/其他

试验官方登记的主要申办方;研究机构申办时会显示相应机构名称。

生产企业

公开药品批准资料或正式说明书暂未提供明确的生产企业信息。

合作机构

  • First Affiliated Hospital of Harbin Medical University研究机构/其他
  • Guizhou Provincial People's Hospital研究机构/其他
  • First Affiliated Hospital of Jinan University研究机构/其他
  • West China Hospital研究机构/其他
  • Suzhou Psychiatric Hospital研究机构/其他
  • Nanjing Medical University研究机构/其他
  • Wuhan Mental Health Centre研究机构/其他
  • Seventh People's Hospital of Hangzhou研究机构/其他
  • First Affiliated Hospital of Kunming Medical University研究机构/其他
  • General Hospital of Ningxia Medical University研究机构/其他
  • The First Affiliated Hospital of Nanchang University研究机构/其他
  • The Second Affiliated Hospital of Xinxiang Medical UniversityUNKNOWN

研发企业与生产企业可能不是同一家。研究阶段药品可能尚未公布生产企业;生产企业仅取自美国上市原研药说明书所列企业(不含仿制药),不作推测;仅在其他国家上市的药品暂无法显示。

研究简介(原文)

This study includes a sequenced clinical trial in order to assess the efficacy of several switching or augment strategies when initial treatment is ineffective,and to provide strong evidence for clinical practice and international guidelines for Obsessive-Compulsive Disorder treatments.

适应症

Obsessive-Compulsive Disorder

主动联系研究团队

总联系人(申办方/研究总部)

中国/港澳台研究中心

问自己是否符合条件、如何预筛

我的病情档案

管理档案

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英文版(发给研究团队)

Dear Study Team,

I am a patient in China and I am interested in participating in your clinical trial:

Study Title: Pragmatic Trial of Obsessive-compulsive Disorder
ClinicalTrials.gov Identifier: NCT04539951
Sponsor: Shanghai Mental Health Center
Investigational product: Sertraline 200 milligram(mg), Sertraline 300 milligram(mg), Fluvoxamine, Venlafaxine, Augment with Memantine

About me:
- Age: (please fill in)
- Sex: (please fill in)
- Confirmed diagnosis and stage: (please fill in)
- Biomarkers / genetic testing: not available
- Prior and current treatments: (please fill in)
- Performance status (ECOG): not assessed
- Current location: China
- Travel ability: (please fill in)

Could you please let me know:
1. Whether I might be eligible for this study;
2. Which site would be closest and most practical for me, and whether remote pre-screening is possible;
3. What documents (medical records, pathology or imaging reports, recent labs) I should prepare for pre-screening.

I can provide English translations of my medical records. Thank you very much for your time and help.

Kind regards,
(your name)
(your email / phone with country code)

中文对照(供您核对)

尊敬的研究团队:

我是一位来自中国的患者,希望咨询参加以下临床试验的可能:

研究名称:Pragmatic Trial of Obsessive-compulsive Disorder
试验编号:NCT04539951
申办方:Shanghai Mental Health Center
研究药物:Sertraline 200 milligram(mg)、Sertraline 300 milligram(mg)、Fluvoxamine、Venlafaxine、Augment with Memantine

我的基本情况:
- 年龄:(请填写)
- 性别:(请填写)
- 确诊疾病与分期:(请填写)
- 基因/标志物检测:暂无
- 既往及当前治疗:(请填写)
- 体能状态(ECOG):未评估
- 目前所在城市:中国
- 可前往范围:(请填写)

想请教三个问题:
1. 我是否可能符合本研究的入组标准?
2. 哪个中心对我最方便可行?能否远程预筛?
3. 预筛需要准备哪些资料(病历、病理、影像、近期化验)?

我可以提供英文翻译版病历。感谢您的时间与帮助。

顺祝安康
(您的姓名)
(您的邮箱/带国际区号的电话)
用邮件客户端发送给 wangzhen@smhc.org.cn

提示:请与主治医生一起发信——由医生署名的申请,回复率远高于患者单独发信。首封邮件不要附身份证号等敏感信息。研究团队通常在 3–10 个工作日内回复,两周无回音可礼貌追问一次。

下一步怎么做?

  1. 把本页信息带给您的主治医生,评估是否适合参加。
  2. 点击下方按钮打开官方注册页,查看研究中心联系方式。
  3. 直接联系研究团队咨询报名事宜(通常有中文同声翻译服务可协助沟通)。
在 ClinicalTrials.gov 查看官方页面