DepressionNCT04555408
Efficacy of Blue Light Treatment in Patients With Nonseasonal Major Depressive Disorder
A study testing blue light, bright light and dim light in people with Depression, run by Shanghai Zhongshan Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Depression
- What is being tested?
- blue light, bright light and dim light
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- meet criteria for major depressive episodes as determined by MINI
- HAMD17≥17
- received antidepressive medication at stable dosages for at least 14 days
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
To compare the efficacy of blue light, bright light and dim light in the treatment of with nonseasonal major depression disorder(MDD) in adults.
Read the detailed description
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
- Depression
- Being tested
- blue light, bright light, dim light
- Keywords
- nonseasonal major depression disorder, light therapy
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blue lightDevice
Patients receive exposure to 100lux blue light, which dominant wave-length is 468nm for 30 minutes in the morning.
bright lightDevice
Patients receive exposure to 1000lux bright light, which dominant wave-length is 490nm for 30 minutes in the morning.
dim lightDevice
Patients receive exposure to 100lux dim light, which dominant wave-length is 490nm for 30 minutes in the morning.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: dim light |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from baseline to 8 weeks
Secondary outcomes (9)
Change in Quick Inventory of Depressive Symptoms, Self-Rated version (QIDS-SR)
It's a self-rated inventory which assesses the severity of depression symptom
Measured: from baseline to 8 weeks
Change in 14-item Hamilton Anxiety Rating Scale (HAMA14)
It assesses the severity of anxiety symptom.
Measured: from baseline to 8 weeks
Change in Pittsburgh sleep quality index (PSQI)
It assesses the quality of sleep.
Measured: from baseline to 8 weeks
Change in Clinical Global Impression scale(CGI)
It gives an overall clinical impression to the continuous outcome measures.
Measured: from baseline to 8 weeks
Change in Quality of Life, Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
It assesses the quality of life, enjoyment and satisfaction
Measured: from baseline to 8 weeks
Change in Morningness-Eveningness Questionnaire (MEQ)
It assesses the circadian phase
Measured: from baseline to 8 weeks
Change in Repeatable Battery for the Assessment of Neuropsychological Status(RBANS)
It assesses cognitive function
Measured: from baseline to 8 weeks
Change in subjective fatigue symptom scale
It assesses subjective fatigue symptom related to the light therapy
Measured: from baseline to 8 weeks
Change in semantic differential scale
It assesses subjective feeling related to the light therapy
Measured: from baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start1 Oct 2020 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Mental Health Center, Jingan District, Shanghai Mental Health Center, Yangpu District, Fudan University
- Responsible party
- Sponsor
- Investigators
- Yuan Wang, MD, Principal investigator, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04555408
- Sponsor's protocol ID
- 2019ZSQN44
- Status last verified
- Jul 2020
- First submitted
- 15 Sep 2020
- Last updated
- 18 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Blue Light Treatment in Patients With Nonseasonal Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT04555408
- Acronym / sponsor ID
- 2019ZSQN44
- Conditions
- Depression
- Keywords
- nonseasonal major depression disorder, light therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- Shanghai Mental Health Center, Jingan District, Shanghai Mental Health Center, Yangpu District, Fudan University
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 18 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| blue light group | Active comparator | Device: blue lightThe 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. |
| bright light group | Active comparator | Device: bright lightThe 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. |
| dim light group | Placebo comparator | Device: dim lightThe 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- meet criteria for major depressive episodes as determined by MINI
- HAMD17≥17
- received antidepressive medication at stable dosages for at least 14 days
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blue lightPatients receive exposure to 100lux blue light, which dominant wave-length is 468nm for 30 minutes in the morning. | Device | blue light group |
| bright lightPatients receive exposure to 1000lux bright light, which dominant wave-length is 490nm for 30 minutes in the morning. | Device | bright light group |
| dim lightPatients receive exposure to 100lux dim light, which dominant wave-length is 490nm for 30 minutes in the morning. | Device | dim light group |
Primary outcome
Change in 17-item Hamilton Depression Rating Scale (HAMD17)
Time frame: from baseline to 8 weeks
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.
9 secondary outcomes
Change in Quick Inventory of Depressive Symptoms, Self-Rated version (QIDS-SR)
Time frame: from baseline to 8 weeks
Change in 14-item Hamilton Anxiety Rating Scale (HAMA14)
Time frame: from baseline to 8 weeks
Change in Pittsburgh sleep quality index (PSQI)
Time frame: from baseline to 8 weeks
Change in Clinical Global Impression scale(CGI)
Time frame: from baseline to 8 weeks
Change in Quality of Life, Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Time frame: from baseline to 8 weeks
Change in Morningness-Eveningness Questionnaire (MEQ)
Time frame: from baseline to 8 weeks
Change in Repeatable Battery for the Assessment of Neuropsychological Status(RBANS)
Time frame: from baseline to 8 weeks
Change in subjective fatigue symptom scale
Time frame: from baseline to 8 weeks
Change in semantic differential scale
Time frame: from baseline to 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuan Wang, MD principal investigator
Shanghai Zhongshan Hospital
Questions about this trial
What is this clinical trial studying?
A study testing blue light, bright light and dim light in people with Depression, run by Shanghai Zhongshan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuan Wang, MD (64041990, wang.yuan@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 17-item Hamilton Depression Rating Scale (HAMD17) (time frame: from baseline to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2020.