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輔助光治療對「夜晚型」抑鬱症患者的隨機對照計劃
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注册号：

Registration number：

 ChiCTR-IOR-15006937 

最近更新日期：

Date of Last Refreshed on：

 2019-04-11 21:07:30 

注册时间：

Date of Registration：

 2015-08-19 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

輔助光治療對「夜晚型」抑鬱症患者的隨機對照計劃

Public title：

Adjunctive light treatment in major depressive disorder patients with evening chronotype - A randomized controlled trial

注册题目简写：

English Acronym：

Adjunctive light treatment in major depressive disorder patients with evening chronotype

研究课题的正式科学名称：

輔助光治療對「夜晚型」抑鬱症患者的隨機對照計劃

Scientific title：

Adjunctive light treatment in major depressive disorder patients with evening chronotype - A randomized controlled trial

研究课题代号(代码)：

Study subject ID：

 CREC-2014.505T

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：

CUHK_CCT00468

申请注册联系人：

Mandy Yu 

研究负责人：

Prof. Wing Yun Kwok 

Applicant：

Mandy Yu 

Study leader：

Prof. Wing Yun Kwok 

申请注册联系人电话：

Applicant telephone：

 +852 26367593

研究负责人电话：

Study leader's
telephone：

+852 26367748

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 mandyyu@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 ykwing@cuhk.edu.hk

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

 http://www.cct.cuhk.edu.hk/registry/publictrialrecord.aspx?trialid=CUHK_CCT00468

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

 http://www.cct.cuhk.edu.hk/registry/publictrialrecord.aspx?trialid=CUHK_CCT00468

申请注册联系人通讯地址：

Department of Psychiatry, 7/F, Shatin Hospital, 33 A Kung Kok St, Ma On Shan, Hong Kong, China

研究负责人通讯地址：

Department of Psychiatry, 7/F, Shatin Hospital, 33 A Kung Kok St, Ma On Shan, Hong Kong, China

Applicant address：

Department of Psychiatry, 7/F, Shatin Hospital, 33 A Kung Kok St, Ma On Shan, Hong Kong, China

Study leader's address：

Department of Psychiatry, 7/F, Shatin Hospital, 33 A Kung Kok St, Ma On Shan, Hong Kong, China

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

香港中文大學

Applicant's institution：

The Chinese University of Hong Kong

研究负责人所在单位：

香港中文大學

Affiliation of the Leader：

The Chinese University of Hong Kong

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 2014.505-T

伦理委员会批件附件：

Approved file of Ethical Committee：

批准本研究的伦理委员会名称：

香港中文大學-新界東醫院聯網臨床研究倫理聯席委員會

Name of the ethic committee：

Joint CUHK-NTEC Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2014-11-10 00:00:00

伦理委员会联系人：

香港中文大學-新界東醫院聯網臨床研究倫理聯席委員會

Contact Name of the ethic committee：

Joint CUHK-NTEC Clinical Research Ethics Committee

伦理委员会联系地址：

Contact Address of the ethic committee：

伦理委员会联系人电话：

Contact phone of the ethic committee：

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

香港中文大學

Primary sponsor：

The Chinese University of Hong Kong

研究实施负责（组长）单位地址：

Department of Psychiatry, 7/F, Shatin Hospital, 33 A Kung Kok St, Ma On Shan, Hong Kong, China

Primary sponsor's address：

Department of Psychiatry, 7/F, Shatin Hospital, 33 A Kung Kok St, Ma On Shan, Hong Kong, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

Health Medical and Research Fund

Source(s) of funding：

Health Medical and Research Fund

研究疾病：

major depressive disorder  

Target disease：

major depressive disorder

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

輔助光治療對「夜晚型」抑鬱症患者  

Objectives of Study：

Adjunctive light treatment in major depressive disorder patients with evening chronotype

药物成份或治疗方案详述：

The current study is a randomized, assessor-blind, parallel-group interventional trial to look into the efficacy of light therapy as an adjunctive therapy in evening-chronotype patients with major depressive disorder. Light therapy group will receive a 5-week daily light therapy.The subjects will be reviewed weekly for the outcome measures and the timing of light therapy will be gradually advanced by each week until a desirable wake time is achieved. TAU subjects will also be prescribed with a 5-week placebo intervention. The placebo condition will be a 30-minute exposure to dim red light (50lux) on the same device. 

Description for medicine or protocol of treatment in detail：

The current study is a randomized, assessor-blind, parallel-group interventional trial to look into the efficacy of light therapy as an adjunctive therapy in evening-chronotype patients with major depressive disorder. Light therapy group will receive a 5-week daily light therapy.The subjects will be reviewed weekly for the outcome measures and the timing of light therapy will be gradually advanced by each week until a desirable wake time is achieved. TAU subjects will also be prescribed with a 5-week placebo intervention. The placebo condition will be a 30-minute exposure to dim red light (50lux) on the same device. 

纳入标准：

Inclusion criteria

排除标准：

1. Major Depressive Disorder fulfilling the Seasonal Pattern Specifier of the DSM-V (Seasonal Affective Disorder);
2. A current diagnosis of substance abuse or dependence;
3. A current or past history of manic or hypomanic episode, schizophrenia, personality disorder, mental retardation, or organic mental disorder;
4. Significant risk of suicide in the opinion of the investigator, or has moderate or above level of suicidality as assessed in the MINI Suicidality Module, or has made a suicide attempt in the past three months;
5. History of light induced migraine/ epilepsy;
6. Current use of photosensitizing medications, e.g. St John's wart;
7. Presence of eye disease: e.g. retinal blindness, severe cataract, glaucoma;
8. Drugs that may interfere with circadian rhythm, i.e. lithium, exogenous melatonin, melatonergic antidepressants within past 3 months;
9. Shift worker;
10. Trans-meridian flight in the past 3 months and during study;
11. Enrolment in any other clinical trial investigational products within one month at the entry of the study;
12. Significant medical condition/ hearing impairment/ speech deficit lead to incapability in completing clinical interview.

Exclusion criteria：

1. Major Depressive Disorder fulfilling the Seasonal Pattern Specifier of the DSM-V (Seasonal Affective Disorder);
2. A current diagnosis of substance abuse or dependence;
3. A current or past history of manic or hypomanic episode, schizophrenia, personality disorder, mental retardation, or organic mental disorder;
4. Significant risk of suicide in the opinion of the investigator, or has moderate or above level of suicidality as assessed in the MINI Suicidality Module, or has made a suicide attempt in the past three months;
5. History of light induced migraine/ epilepsy;
6. Current use of photosensitizing medications, e.g. St John's wart;
7. Presence of eye disease: e.g. retinal blindness, severe cataract, glaucoma;
8. Drugs that may interfere with circadian rhythm, i.e. lithium, exogenous melatonin, melatonergic antidepressants within past 3 months;
9. Shift worker;
10. Trans-meridian flight in the past 3 months and during study;
11. Enrolment in any other clinical trial investigational products within one month at the entry of the study;
12. Significant medical condition/ hearing impairment/ speech deficit lead to incapability in completing clinical interview.

研究实施时间：

Study execute time：

从 From 1990-01-01 00:00:00至 To 1990-01-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2015-09-01 00:00:00 至 To 1990-01-01 00:00:00

干预措施：

Interventions：

组别：

Two groups

样本量：

 114

Group：

Two groups

Sample size：

干预措施：

Light therapy group will receive a 5-week daily light therapy. TAU subjects will also be prescribed with a 5-week placebo intervention.

干预措施代码：

Intervention：

Light therapy group will receive a 5-week daily light therapy. TAU subjects will also be prescribed with a 5-week placebo intervention.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

 The Chinese University of Hong Kong 

单位级别：

 The Chinese University of Hong Kong 

Institution
hospital：

The Chinese University of Hong Kong

Level of the institution：

The Chinese University of Hong Kong

测量指标：

Outcomes：

指标中文名：

remission rate as defined by the HAM-D 17 score

指标类型：

主要指标

Outcome：

remission rate as defined by the HAM-D 17 score

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

the depressive symptoms severity via Structured Interview Guide for the Hamilton Depression Rating Scale with Atypical Depression Supplement (SIGH-ADS)

指标类型：

主要指标

Outcome：

the depressive symptoms severity via Structured Interview Guide for the Hamilton Depression Rating Scale with Atypical Depression Supplement (SIGH-ADS)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

anxiety symptoms (HAM-A, HADS)

指标类型：

次要指标

Outcome：

anxiety symptoms (HAM-A, HADS)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

insomnia symptoms (ISI)

指标类型：

次要指标

Outcome：

insomnia symptoms (ISI)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

suicidal ideation (BSSI)

指标类型：

次要指标

Outcome：

suicidal ideation (BSSI)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

fatigue (CFS)

指标类型：

次要指标

Outcome：

fatigue (CFS)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

quality of life (SF-36)

指标类型：

次要指标

Outcome：

quality of life (SF-36)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

sleep pattern

指标类型：

次要指标

Outcome：

sleep pattern

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 65 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）：

Randomized

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

Randomized

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：

Single-blind

Blinding：

Single-blind

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

否No

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）：

Not stated

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

Not stated

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：

Not stated

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

Not stated

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：

  2015-08-19 15:54:02
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