ClinicalTrials.gg
Status unknownNCT04633707Updated Mar 23, 2021

Adjunctive Bright Light Therapy for Patients With Depression

An interventional study of adjunctive bright white light therapy in the morning and adjunctive bright white light therapy in the afternoon in Depressive Disorder and Light Therapy, sponsored by Guangzhou Psychiatric Hospital. Status unknown at 1 site in China. Open to participants aged 12 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-03-23.

Sponsored by Guangzhou Psychiatric Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
159
Allocation
Randomized
Ages
12 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 54 studies in Depressive Disorder with a site in China — 21 open to participants now, 23 under way, 2 of them phase 3. Depressive Disorder · China.

Planned enrollment
18th of 42
159 · median 120
Started
2021
with 2 others
No phase
28 of 54
12 open now
Registered
22nd of 54
by date
Lead sponsor
2 of 54
Guangzhou Psychiatric Hospital

Among the 54 studies in Depressive Disorder with a site in China, this one is the 18th largest by planned enrollment of the 42 interventional ones, is one of 3 that started in 2021, is one of 28 with no phase, and was the 22nd registered.

By phase

54 studies; the count open now beside each. This study's row is marked.

No phasethis study28 · 12 open
Observational12 · 7 open
Phase 15 · 0 open
Phase 44 · 0 open
Phase 23 · 0 open
Phase 32 · 2 open

By the year they started

First in 2006; this study’s year is marked. 3 started in 2021.

Size and results

Median enrollment 120 across the 42 interventional studies, 180 across the 12 observational. Of the 18 that completed or were terminated, 1 (6%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 54 studies in Depressive Disorder with a site in China, or all of them as a file.
02

Study summary

The study would enroll depressed adolescents and adults with bipolar I or II disorder or major depressive disorder who are receiving stable psychiatric medication (excluding patients with hypomania or mania, mixed symptoms, or rapid cycling). Participants would be randomly assigned to treatment with either 1,0000-lux bright white light therapy in the morning or 1,0000-lux bright white light therapy in the afternoon, or \<100-lux dim red placebo light therapy in the afternoon (N=59 for each group). Participants would be treated for 6 weeks. Symptoms would be assessed every two weeks with the 24-items Hamilton Depression Scale, the Young Mania Rating Scale, and the Pittsburgh Sleep Quality Index; salivary melatonin and cortisol concentrations will be also measured.

Read the detailed description

The investigators would divide the participants enrolled into three groups: adjunctive morning bright light therapy (BLT) group (light intensity: 10000lux, color: white light, duration of each intervention session: 30min, time period of intervention: 7:00\~9:00 a.m.), adjunctive afternoon BLT group (light intensity: 10000lux, color: white light, duration of each intervention session: 30min, time period of intervention: 12:00\~14:00 p.m.), adjunctive placebo therapy group (light intensity: \<100lux, color: dark red, duration of each intervention session: 30min, time period of intervention: 12:00\~14:00 p.m.).

03

Conditions studied

  • Depressive Disorder
  • Light Therapy

Keywords

  • Depression
  • Bright Light Therapy
  • Time Period
04

Who can participate

Ages eligible
12 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 12-75 years old
  • Diagnosed using criteria based on the Structured Clinical Interview for Patient Edition (SCID-P) for adults or Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime version (Kiddie-SADS-PL) for adolescents for the diagnosis of bipolar I or II disorder or major depressive disorder
  • 24-items Hamilton Depression Rating Scale score ≥ 20, Young Mania Rating Scale score \< 6
  • Participants with bipolar disorder taking at least one mood stabilizer, and the types of drugs have not changed in one week;
  • Antidepressants can be taken, and the types of antidepressants have not changed in one week
  • Low-dose benzodiazepines can be used, with a maximum of 2 mg of lorazepam equivalent per day
  • Right-handed
  • Primary school education or above
  • Sign informed consents after a full explanation of this study.

Exclusion criteria

Exclusion Criteria:

  • A history of brain organic disease or severe traumatic brain injury and severe physical disease;
  • Drug, alcohol or other psychoactive substance abusers
  • Severe suicide risk;
  • Received modified electric convulsion therapy (MECT) in the past three months
  • Comorbid with ophthalmic diseases (cataract, macular degeneration, glaucoma, retinitis pigmentosa, etc.) and diseases affecting the retina (retinopathy, diabetes, herpes, etc.)
  • Taking photosensitive drugs (phenothiazines, antimalarials, propranolol, melatonin, hypericum, stimulants or NSAIDs)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
159 participants (estimated)

Study arms

  • Experimental
    Adjunctive morning BLT group

    treat participants with adjunctive BLT in the morning

    Device: adjunctive bright white light therapy in the morning

  • Experimental
    Adjunctive afternoon BLT group

    treat participants with adjunctive BLT in the afternoon

    Device: adjunctive bright white light therapy in the afternoon

  • Placebo comparator
    Adjunctive placebo therapy group

    treat participants with adjunctive dim red light in the afternoon

    Device: adjunctive dim red light therapy in the afternoon

Interventions

  • Deviceadjunctive bright white light therapy in the morning

    the participants would receive adjunctive bright white light therapy in the morning (light intensity: 10000lux, color: white light, duration of each intervention session: 30min, time period: 7:00\~9:00) for 6 weeks.

  • Deviceadjunctive bright white light therapy in the afternoon

    the participants would receive adjunctive bright white light therapy in the afternoon (light intensity: 10000lux, color: white light, duration of each intervention session: 30min, time period: 12:00\~14:00) for 6 weeks.

  • Deviceadjunctive dim red light therapy in the afternoon

    the participants received dim red light therapy (light intensity: \<100lux, color: dark red, duration of each intervention session: 30min, time period: 12:00\~14:00) for 6 weeks.

06

What researchers measure

Primary outcomes

  1. response rate

    Participants with a decrease in 24-items Hamilton Depression Scale (HDRS) score of 50% or more from baseline. HDRS is used to measure the depressive severity;its measured time range is within the past week. In this study, version of 24-items is used. The patients are depressed when the total score are greater than 19 points, and there are no depression when the total scores are less than points.

    Time frame: up to week 6

Secondary outcomes

  1. manic/hypomanic conversion rate

    The Young Mania Rating Scale (YMRS) is used to assess manic/hypomanic symptoms and their severity; its measured time range is within the past week. The higher the score, the more severe the symptom. If the total score is greater than or equal to 20, manic episode is considered; if the total score is less than 6, it means there is no manic/hypomanic symptoms.

    Time frame: week 2; week 4; week 6

  2. side effect

    record the possible adverse reactions

    Time frame: week 2; week 4;week 6

  3. sleep quality

    Pittsburgh Sleep Quality Index (PSQI) is used to evaluate sleep quality for last month. It's made of 7 items; every item is scored 1-4 point. Total score is obtained by adding up the points of 7 items. Total score range is 0\~21 point. The sleep quality is worse when the total score is higher.

    Time frame: week 2; week 4;week 6

07

Study locations

1 site
  • Guangzhou Brain Hospital (Guangzhou Huiai Hospital)
    Guanzhou, Guangdong 510370, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Mar 2021; primary completion for May 2022, 14 months later.

Of 260 non-industry interventional studies with no phase under Depressive Disorder, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 46. This study's planned 14 months is below that.

Counting every sponsor, half of 274 studies reached it within 29 months; a quarter within 15 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 12, 2020
First posted
Nov 18, 2020
StartEst.
Mar 2021
Primary completionEst.
May 2022
CompletionEst.
Jul 2022
Last update
Mar 23, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 23, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04633707
Lead sponsor
Guangzhou Psychiatric Hospital
Responsible party
Kangguang Lin (Director, Guangzhou Psychiatric Hospital) — Principal investigator
First posted
Nov 18, 2020
Start date
Mar 2021 (estimated)
Primary completion
May 2022 (estimated)
Completion
Jul 2022 (estimated)
Last update
Mar 23, 2021

Study contacts

Lin Kangguang, MD;PHD
Contact
linkangguang@163.com
13560360144 ext. 18028619981
Liu Tao, MD
Contact
liutaolp@163.com
15017554527
Lin Kangguang, MD;PHD
principal investigator · Guangzhou Psychiatric Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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