Efficacy of Blue Light Treatment in Patients With Nonseasonal Major Depressive Disorder

NCT ID: NCT04555408

Last Updated: 2020-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2022-12-31

Brief Summary

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To compare the efficacy of blue light, bright light and dim light in the treatment of with nonseasonal major depression disorder(MDD) in adults.

Detailed Description

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The current study aims to compare the efficacy of blue light, bright light and dim light in the treatment of with nonseasonal major depression disorder(MDD) in adults. 162 patients with nonseasonal MDD will be randomized into three groups (i.e. blue light, bright light or dim light). The treatment will be performed five times a week for the first two weeks. And for the next 2 weeks, the treatment for patients will be undertook three times a week. There will be 16 times in total. The investigators will assess nonseasonal MDD'symptom severity in the baseline, 1 week,2 week, 4 week,6 week and 8 week. Through the study, 17-item Hamilton Depression Rating Scale (HAMD17),14-item Hamilton Anxiety Rating Scale (HAMA14),Quick Inventory of Depressive Symptoms, Self-Rated version (QIDS-SR),Pittsburgh sleep quality index (PSQI) , Clinical Global Impression scale(CGI), Quality of Life, Enjoyment and Satisfaction Questionnaire (Q-LES-Q),Morningness-Eveningness Questionnaire (MEQ),Repeatable Battery for the Assessment of Neuropsychological Status(RBANS),subjective fatigue symptom scale and semantic differential scale will be obtained. The patients will also get individual's data of heart rate and blood pressure.

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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blue light group

The blue light will be applied five times a week for the first two weeks. For the next two weeks, this treatment will be applied three times a week.

Group Type ACTIVE_COMPARATOR

blue light

Intervention Type DEVICE

Patients receive exposure to 100lux blue light, which dominant wave-length is 468nm for 30 minutes in the morning.

bright light group

The bright light will be applied five times a week for the first two weeks. For the next two weeks, this treatment will be applied three times a week.

Group Type ACTIVE_COMPARATOR

bright light

Intervention Type DEVICE

Patients receive exposure to 1000lux bright light, which dominant wave-length is 490nm for 30 minutes in the morning.

dim light group

The dim light will be applied five times a week for the first two weeks. For the next two weeks, this treatment will be applied three times a week.

Group Type PLACEBO_COMPARATOR

dim light

Intervention Type DEVICE

Patients receive exposure to 100lux dim light, which dominant wave-length is 490nm for 30 minutes in the morning.

Interventions

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blue light

Patients receive exposure to 100lux blue light, which dominant wave-length is 468nm for 30 minutes in the morning.

Intervention Type DEVICE

bright light

Patients receive exposure to 1000lux bright light, which dominant wave-length is 490nm for 30 minutes in the morning.

Intervention Type DEVICE

dim light

Patients receive exposure to 100lux dim light, which dominant wave-length is 490nm for 30 minutes in the morning.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* meet criteria for major depressive episodes as determined by MINI
* HAMD17≥17
* received antidepressive medication at stable dosages for at least 14 days

Exclusion Criteria

* Any axis I psychiatric disorder comorbidity
* who have received formal psychological therapy, MECT or rTMS in 3 months
* any current significant medical condition especially eye diseases
* serious suicide risk
* pregnant or breastfeeding women
* depression with seasonal pattern
* treatment-resistant depression
* epilepsy in the past
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Mental Health Center, Jingan District

OTHER

Sponsor Role collaborator

Shanghai Mental Health Center, Yangpu District

UNKNOWN

Sponsor Role collaborator

Fudan University

OTHER

Sponsor Role collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yuan Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Zhongshan Hospital

Central Contacts

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Yuan Wang, MD

Role: CONTACT

Xiao Huang, MD,PhD

Role: CONTACT

Other Identifiers

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2019ZSQN44

Identifier Type: -

Identifier Source: org_study_id

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