ChiCTR2300073236 版本V1.1 版本创建时间2023/08/31 16:59:52 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2300073236 

最近更新日期：

Date of Last Refreshed on：

2023-07-05 08:43:39 

注册时间：

Date of Registration：

2023-07-05 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

混合策略电抽搐治疗双相情感障碍躁狂相患者的疗效及安全性的双盲随机对照试验

Public title：

A study on the efficacy and safety of hybrid electroconvulsive therapy in patients with manic phase of bipolar disorder

注册题目简写：

English Acronym：

研究课题的正式科学名称：

混合策略电抽搐治疗双相情感障碍躁狂相患者的疗效及安全性的双盲随机对照先行性试验

Scientific title：

A study on the efficacy and safety of hybrid electroconvulsive therapy in patients with manic phase of bipolar disorder

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

叶飞英 

研究负责人：

叶飞英 

Applicant：

Ye Feiying 

Study leader：

Ye Feiying 

申请注册联系人电话：

Applicant telephone：

+86 136 6951 2692

研究负责人电话：

Study leader's telephone：

+86 136 6951 2692

申请注册联系人传真 ：

Applicant Fax：

+86 752 2182500

研究负责人传真：

Study leader's fax：

+86 752 2182500

申请注册联系人电子邮件：

Applicant E-mail：

gdhzyfy083@163.com

研究负责人电子邮件：

Study leader's E-mail：

gdhzyfy083@163.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

惠州市惠城区下角惠州市第二人民医院

研究负责人通讯地址：

惠州市惠城区下角惠州市第二人民医院

Applicant address：

Huizhou Second People's Hospital, Xiajiao, Huicheng District, Huizhou City

Study leader's address：

Huizhou Second People's Hospital, Xiajiao, Huicheng District, Huizhou City

申请注册联系人邮政编码：

Applicant postcode：

516001

研究负责人邮政编码：

Study leader's postcode：

516001

申请人所在单位：

惠州市第二人民医院

Applicant's institution：

Huizhou Second People's Hospital

研究负责人所在单位：

惠州市第二人民医院

Affiliation of the Leader：

Huizhou Second People's Hospital

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

2023-05

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

惠州市第二人民医院伦理委员会

Name of the ethic committee：

Ethics Committee of the Second People's Hospital of Huizhou

伦理委员会批准日期：

Date of approved by ethic committee：

2023-03-06 00:00:00

伦理委员会联系人：

谭钊

Contact Name of the ethic committee：

Tan Zhao

伦理委员会联系地址：

惠州市惠城区下角惠州市第二人民医院

Contact Address of the ethic committee：

Huizhou Second People's Hospital, Xiajiao, Huicheng District, Huizhou City

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 752 218 2902

伦理委员会联系人邮箱：

Contact email of the ethic committee：

3582027891@qq.com

研究实施负责（组长）单位：

惠州市第二人民医院

Primary sponsor：

The Second People's Hospital of Huizhou

研究实施负责（组长）单位地址：

惠州市惠城区下角惠州市第二人民医院

Primary sponsor's address：

Huizhou Second People's Hospital, Xiajiao, Huicheng District, Huizhou City

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中华人民共和国

省(直辖市)：

广东

市(区县)：

惠州

Country：

PR China

Province：

Guangdong

City：

Huizhou

单位(医院)：

惠州市第二人民医院

具体地址：

菱湖二路17号惠州市惠城区下角惠州市第二人民医院

Institution
hospital：

The Second People's Hospital of Huizhou

Address：

17#, No.2 Linghu Road, The Second People's Hospital of Huizhou

经费或物资来源：

医院自筹

Source(s) of funding：

Hospital

Target disease：

Manic episodes of bipolar disorder

Target disease code：

F31.1; F31.2

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 治疗新技术临床试验 

Study phase：

New Treatment Measure Clinical Study

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

探索HECT在双相情感障碍躁狂患者的疗效及安全性  

Objectives of Study：

To explore the efficacy and safety of HECT in patients with bipolar disorder mania

药物成份或治疗方案详述：

一名指定的研究者负责将符合入组标准的70例双相躁狂发作患者随机分为2组，试验组为HECT组，对照组为ECT组。Hybrid-ECT治疗组（治疗组）前四次的治疗和ECT组一样均为常规ECT，之后的治疗为LCE，其能量降低电量到阈值的 1/2，刺激持续时间= 0.5 s，频率= 20 Hz，和本研究团队之前的研究一致[20]。ECT治疗组（对照组）的所有治疗均为常规ECT。两组在每个治疗期间使用阿托品来抑制腺体分泌物。 刺激电极放置于双侧颞极方式（BT），并同时记录治疗过程中的脑电图(EEG)以便判断和记录患者的发作情况。在BT电极放置中，两个电极应用于连接眼睛外眼角线和头部两侧外耳道线的中点上方2-3厘米[21, 22]。术前麻醉采用依托咪酯0.15-0.3mg/kg静脉注射，肌松剂使用氯化琥珀胆碱1-1.5mg/kg，Hybrid-ECT和ECT的过程中全程给予100 %纯氧。Hybrid-ECT/ECT的治疗次数设定及终止条件：Hybrid-ECT/ECT每周一、三、五进行，Hybrid-ECT/ECT的最少治疗次数为6次，在6次治疗后，患者的主治医师依据患者的病情决定是否继续需要治疗：当患者YMRS得分<6时停止治疗转为随访；为了进一步保障患者的权益，当随着治疗的进行但患者的病情不再随着治疗的继续而改善时停止。Hybrid-ECT/ECT的治疗次数最多不超过12次。在Hybrid-ECT/ECT疗程结束后，患者继续服用原先的治疗药物。当发生严重安全事件时，应当立即终止该名被试的试验并揭盲以便进一步处理。在整个试验期间的任何时刻，被试均有权决定退出。合并药物的处理：在试验阶段，可视患者个体情况给予情感稳定剂或者第二代抗精神病药物，但情感稳定剂在HECT/ECT治疗前16小时应禁用，在试验进行中，不调整药物品种。当患者失眠时，可临时给予佑佐匹克隆或者唑吡坦等助眠，伴激越患者可临时给予安定针剂，安定类药物亦应在HECT/ECT治疗前16小时及量表评定前24h禁用，其余用药禁忌和规范同常规ECT治疗。 

Description for medicine or protocol of treatment in detail：

A designated investigator randomly assigned 70 eligible patients with a bipolar manic episode to HECT in the experimental group or ECT in the control group. The first four treatments of the Hybrid ECT treatment group (treatment group) were all conventional ECT as the ECT group, and the subsequent treatment was LCE, in which the energy was reduced to 1/2 of the threshold, the stimulation duration was 0.5 s, and the frequency was 20 Hz, which was consistent with the previous study of our research team [20]. The ECT group (control group) received conventional ECT for all treatments. Atropine was used to suppress glandular secretions in both groups during each treatment period. Stimulating electrodes were placed in bilateral temporal pole mode (BT), and electroencephalogram (EEG) was recorded during the treatment to judge and record the seizures of patients. In BT electrode placement, two electrodes are applied 2-3 cm above the midpoint connecting the canthus line outside the eye and the line of the external auditory canal on both sides of the head [21, 22]. Intravenous etomidate 0.15-0.3mg/kg was used for preoperative anesthesia, succinylcholine chloride 1-1.5mg/kg was used for muscle relaxant, and 100% pure oxygen was given during the whole process of Hybrid ECT and ECT. Frequency setting and termination conditions of Hybrid ECT/ECT: Hybrid ECT/ECT is performed every Monday, Wednesday and Friday, and the minimum number of treatments of Hybrid ECT/ECT is 6. After the 6 treatments, the patient's attending physician decides whether to continue the treatment according to the patient's condition: When the patient's YMRS score < At 6 o 'clock, the treatment was stopped and followed up. In order to further protect the rights and interests of patients, it is stopped when the patient's condition is no longer improved with the continuation of treatment. The maximum number of treatment sessions for Hybrid /ECT was 12. After the completion of the course of mixed-ECT /ECT, patients continued to take their original treatment drugs. In the event of a serious safety incident, the subject's trial should be immediately terminated and unblinded for further treatment. At any point throughout the trial, the subject had the right to withdraw. Treatment of concomitant drugs: During the trial phase, mood stabilizers or second-generation antipsychotic drugs could be given depending on the individual patient's condition, but mood stabilizers should be prohibited 16 hours before HECT/ECT treatment, and the drug type should not be adjusted during the trial. Diazepam injection can be given to patients with agitation. Diazepam should also be banned 16 hours before HECT and 24 hours before scale assessment. Other medication contraindications and standards are the same as conventional ECT treatment. 

纳入标准：

1）18岁<年龄<60岁，2）根据ICD-10诊断为双相情感障碍，目前为躁狂发作，伴或不伴精神病性症状的住院患者；3）杨氏躁狂量表（YMRS）≥20分；4）可签署知情同意书。

Inclusion criteria

1) 18 years old < Age < 60 years old, 2) hospitalized patients with bipolar disorder diagnosed according to ICD-10 and current manic episode, with or without psychotic symptoms; 3) Young Mania Scale (YMRS) ≥20; 4) Informed consent can be signed.

排除标准：

1）怀孕；2）入组前30天内参与过其他相关研究者；3）入组前6个月内接受过ECT或者rTMS治疗；4）之前对ECT效果欠佳；5）在精神活性物质滥用史；6）存在ECT相关禁忌症；7）存在心血管疾病等麻醉风险；8）存在癫痫病史；9）非惠州市常住居民，或地址不详不愿意接受随访者。

Exclusion criteria：

1) pregnancy; 2) participated in other relevant investigators within 30 days before enrollment; 3) received ECT or rTMS within 6 months before enrollment; 4) previous poor response to ECT; 5) history of psychoactive substance abuse; 6) presence of ECT related contraindications; 7) there are anesthetic risks such as cardiovascular diseases; 8) a history of epilepsy; 9) Those who are not permanent residents of Huizhou or whose address is unknown are not willing to accept follow-up visits.

研究实施时间：

Study execute time：

从 From 2023-07-01 00:00:00至 To 2025-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2023-07-01 00:00:00 至 To 2025-06-30 00:00:00  

干预措施：

Interventions：

组别：

ECT组

样本量：

37

Group：

ECT Group

Sample size：

干预措施：

常规电抽搐疗法(ECT)

干预措施代码：

Intervention：

Standard Electroconvulsive therapy (ECT)

Intervention code：

组别：

混合策略ECT组

样本量：

37

Group：

HECT Group

Sample size：

干预措施：

混合策略ECT

干预措施代码：

Intervention：

Hybrid-ECT

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中华人民共和国

省(直辖市)：

 广东 

市(区县)：

 惠州 

Country：

PR China 

Province：

Guangdong 

City：

Huizhou 

单位(医院)：

惠州市第二人民医院 

单位级别：

三级 

Institution
hospital：

The Second People's Hospital of Huizhou

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

杨氏躁狂量表

指标类型：

主要指标

Outcome：

YMRS

Type：

Primary indicator

测量时间点：

基线、转换前、12次（或最后1次）Hybrid-ECT/ECT后和随访结束时（随访期为30天）

测量方法：

经培训的固定两位心理治疗师进行评估

Measure time point of outcome：

Baseline, before conversion, after 12 (or last) HEMD-ECT /ECT, and at the end of follow-up (follow-up period was 30 days)

Measure method：

Two trained psychotherapists conducted the assessment

指标中文名：

蒙哥马利抑郁评定量表 (MADRS)

指标类型：

次要指标

Outcome：

Montgomery -Asberg Depression Rating Scale

Type：

Secondary indicator

测量时间点：

基线、转换前、12次（或最后1次）Hybrid-ECT/ECT后和随访结束时（随访期为30天）

测量方法：

经培训的固定两位心理治疗师进行评估

Measure time point of outcome：

Baseline, before conversion, after 12 (or last) HEMD-ECT /ECT, and at the end of follow-up (follow-up period was 30 days)

Measure method：

Two trained psychotherapists conducted the assessment

指标中文名：

阳性和阴性症状量表(PANSS)

指标类型：

次要指标

Outcome：

Positive and Negative Symptom Scales

Type：

Secondary indicator

测量时间点：

基线、转换前、12次（或最后1次）Hybrid-ECT/ECT后和随访结束时（随访期为30天）

测量方法：

经培训的固定两位心理治疗师进行评估

Measure time point of outcome：

Baseline, before conversion, after 12 (or last) HEMD-ECT /ECT, and at the end of follow-up (follow-up period was 30 days)

Measure method：

Two trained psychotherapists conducted the assessment

指标中文名：

斯特鲁测验

指标类型：

次要指标

Outcome：

Stroop Test

Type：

Secondary indicator

测量时间点：

基线、转换前、12次（或最后1次）Hybrid-ECT/ECT后和随访结束时（随访期为30天）

测量方法：

经培训的固定两位心理治疗师进行测评

Measure time point of outcome：

Baseline, before conversion, after 12 (or last) HEMD-ECT /ECT, and at the end of follow-up (follow-up period was 30 days)

Measure method：

Two trained psychotherapists conducted the evaluation

指标中文名：

神经心理状态评估可重复性系列测验

指标类型：

次要指标

Outcome：

Repeatable Battery for the Assessment of Neuropsychological Status,RBANS

Type：

Secondary indicator

测量时间点：

基线、转换前、12次（或最后1次）Hybrid-ECT/ECT后和随访结束时（随访期为30天）

测量方法：

经培训的固定两位心理治疗师进行测评

Measure time point of outcome：

Baseline, before conversion, after 12 (or last) HEMD-ECT /ECT, and at the end of follow-up (follow-up period was 30 days)

Measure method：

Two trained psychotherapists conducted the evaluation

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

Blood

Tissue：

人体标本去向

 使用后保存  

说明

Fate of sample：

Preservation after use  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 60 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

使用计算机按照1:1生成随机序列。

Randomization Procedure (please state who generates the random number sequence and by what method)：

A 1:1 random sequence is generated using a computer.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

对被试本人和疗效评定者设盲

Blinding：

Blinding of participants and efficacy evaluators

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

Yes

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

试验完成后6个月内，方式为EXCEL 表格，电子邮件。

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

In six months after the trail,by email the excel files.

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

EXCEL表格

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Excel files

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2023-07-05 08:43:15