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Trial History Detail on 2018-04-10

CUHK_CCT00468

2015-08-18

Prospective

CREC-2014.505T

Health Medical and Research Fund

The Chinese University of Hong Kong

NA

Not Applicable

Mandy Yu

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

26367593

mandyyu@cuhk.edu.hk

The Chinese University of Hong Kong

Hong Kong

Prof. Wing Yun Kwok

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

26367748

ykwing@cuhk.edu.hk

The Chinese University of Hong Kong

Hong Kong

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

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

輔助光治療對「夜晚型」抑鬱症患者的隨機對照計劃

Adjunctive light treatment in major depressive disorder patients with evening chronotype

Hong Kong

Yes

2014-11-10

Joint CUHK-NTEC Clinical Research Ethics Committee

2014.505-T

major depressive disorder

Other

Light therapy

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.

bright light

10000 lux

5 weeks

30mins daily

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.

dim red light

50 lux

5 weeks

30mins daily

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

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

18

65

Both Male and Female

Interventional

Randomized

single randomization

Placebo

Single-blind

Investigator/research team

Parallel

3

2015-09-01

114

Recruiting

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.

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

No

2019-04-11

ChiCTR-IOR-15006937

2015-08-19

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