NCT04555408

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
162

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable depression

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 18, 2020

Completed
13 days until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

September 18, 2020

Status Verified

July 1, 2020

Enrollment Period

2 years

First QC Date

September 15, 2020

Last Update Submit

September 15, 2020

Conditions

Depression

Keywords

nonseasonal major depression disorderlight therapy

Outcome Measures

Primary Outcomes (1)

  • Change in 17-item Hamilton Depression Rating Scale (HAMD17)

    It assesses the severity of depression symptom. The responder on HAMD17 is defined as a HAMD17 decrease at least 50% from the baseline at post-treatment.

    from baseline to 8 weeks

Secondary Outcomes (9)

  • Change in Quick Inventory of Depressive Symptoms, Self-Rated version (QIDS-SR)

    from baseline to 8 weeks

  • Change in 14-item Hamilton Anxiety Rating Scale (HAMA14)

    from baseline to 8 weeks

  • Change in Pittsburgh sleep quality index (PSQI)

    from baseline to 8 weeks

  • Change in Clinical Global Impression scale(CGI)

    from baseline to 8 weeks

  • Change in Quality of Life, Enjoyment and Satisfaction Questionnaire (Q-LES-Q)

    from baseline to 8 weeks

  • +4 more secondary outcomes

Study Arms (3)

blue light group

ACTIVE COMPARATOR

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.

Device: blue light

bright light group

ACTIVE COMPARATOR

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.

Device: bright light

dim light group

PLACEBO COMPARATOR

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.

Device: dim light

Interventions

blue lightDEVICE

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

blue light group
bright lightDEVICE

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

bright light group
dim lightDEVICE

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

dim light group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Yuan Wang, MD

    Shanghai Zhongshan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuan Wang, MD

CONTACT

64041990wang.yuan@zs-hospital.sh.cn

Xiao Huang, MD,PhD

CONTACT

64041990slehuang@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2020

First Posted

September 18, 2020

Study Start

October 1, 2020

Primary Completion

October 1, 2022

Study Completion

December 1, 2022

Last Updated

September 18, 2020

Record last verified: 2020-07