Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00468

2 Trial Registration Date

2015-08-18

i Registration Status

Prospective

3 Secondary IDs

CREC-2014.505T

4 Source(s) of Funding

Health Medical and Research Fund

5 Primary Sponsor

The Chinese University of Hong Kong

6 Secondary Sponsor

NA

Function

Not Applicable

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Mandy Yu

ii Address

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

iii Phone

26367593

iv Email

mandyyu@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

Hong Kong

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Prof. Wing Yun Kwok

ii Address

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

iii Phone

26367748

iv Email

ykwing@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

Hong Kong

9 Official Scientific Title of the Study

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

10 Public Title

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

i Public Title in Chinese 研究名稱

輔助光治療對「夜晚型」抑鬱症患者的隨機對照計劃

11 Short Title (Optional)

Adjunctive light treatment in major depressive disorder patients with evening chronotype

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2014-11-10

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2014.505-T

14 Medical Condition Being Studied

major depressive disorder

15 Intervention

i Types of intervention

Other

Please specify

Light therapy

ii Description/ name of Intervention/article

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.

iii Dosage form of the intervention

bright light

iv Dosage of the intervention

10000 lux

v Duration of the intervention

5 weeks

vi Frequency of the intervention

30mins daily

16 Comparative Treatments

i Description/ name of comparative treatments

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.

ii Dosage form of the comparative treatments

dim red light

iii Dosage of the comparative treatments

50 lux

iv Duration of the comparative treatments

5 weeks

v Frequency of the comparative treatments

30mins daily

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

1.Aged 18-65;
2.Is capable of giving informed consent;
3.Meet diagnostic criteria of major depressive disorder (MDD) by the Mini-Neuropsychiatric Interview (MINI);
4.Score at least 14 on the 17-item Hamilton Rating Scale for Depression (HAM-D17);
5.Evening chronotype

ii 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

iii Age Minimum

18

iv Age Maximum

65

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

single randomization

ii Nature of control

Placebo

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

Investigator/research team

iv Group Assignment

Parallel

v Study Phase

3

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2015-09-01

21 Target Sample Size

114

22 Recruitment Status

Recruiting

23 Primary Outcome

Primary outcomes will include remission rate as defined by the HAM-D 17 score of 7 or less and the depressive symptoms severity via Structured Interview Guide for the Hamilton Depression Rating Scale with Atypical Depression Supplement (SIGH-ADS).
All the study subjects will be assessed by the clinicians and independent assessors separately during baseline, across 5-week intervention period, week 6, week 10, week 14 and week 26.

24 Secondary Outcome

Secondary outcomes include anxiety symptoms (HAM-A, HADS), insomnia symptoms (ISI), suicidal ideation (BSSI), fatigue (CFS), quality of life (SF-36) and sleep pattern.
All the study subjects will be assessed by the clinicians and independent assessors separately during baseline, across 5-week intervention period, week 6, week 10, week 14 and week 26

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2019-04-11

27 Primary Registry and Trial Identifying Number

ChiCTR-IOR-15006937

28 Date of Registration in Primary Registry

2015-08-19

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Trial History Detail on 2017-03-17