Depressive DisorderNCT04633707
Adjunctive Bright Light Therapy for Patients With Depression
A study testing adjunctive bright white light therapy in the morning, adjunctive bright white light therapy in the afternoon and adjunctive dim red light therapy in the afternoon in people with Depressive Disorder and Light Therapy, run by Guangzhou Psychiatric Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Depressive Disorder, Light Therapy
- What is being tested?
- adjunctive bright white light therapy in the morning, adjunctive bright white light therapy in the afternoon and adjunctive dim red light therapy in the afternoon
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 159 participants
- Where
- 1 siteChina
- Study dates
- Mar 2021to Jul 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 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 12-75 years old
- Diagnosed using DSM-5 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
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- Right-handed
- Primary school education or above
- Sign informed consents after a full explanation of this study.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
China1 site
Guangzhou Brain Hospital (Guangzhou Huiai Hospital)
Guanzhou, Guangdong, 510370
About this study
Official title: Adjunctive Bright Light Therapy for Patients With Depression at Different Time Period: A Randomized Double-Blind, Placebo-Controlled Trial
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.).
- Conditions
- Depressive Disorder, Light Therapy
- Being tested
- adjunctive bright white light therapy in the morning, adjunctive bright white light therapy in the afternoon, adjunctive dim red light therapy in the afternoon
- Keywords
- Depression, Bright Light Therapy, Time Period
- Medical subject headings
- Depressive Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adjunctive bright white light therapy in the morningDevice
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.
adjunctive bright white light therapy in the afternoonDevice
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.
adjunctive dim red light therapy in the afternoonDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Adjunctive morning BLT group | Experimental | treat participants with adjunctive BLT in the morning Receives: Device: adjunctive bright white light therapy in the morning |
| Adjunctive afternoon BLT group | Experimental | treat participants with adjunctive BLT in the afternoon Receives: Device: adjunctive bright white light therapy in the afternoon |
| Adjunctive placebo therapy group | Placebo comparator | treat participants with adjunctive dim red light in the afternoon Receives: Device: adjunctive dim red light therapy in the afternoon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to week 6
Secondary outcomes (3)
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.
Measured: week 2; week 4; week 6
side effect
record the possible adverse reactions
Measured: week 2; week 4;week 6
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.
Measured: week 2; week 4;week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study startMar 2021 (estimated)
- Primary completionMay 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 159 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Psychiatric Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Kangguang Lin, Guangzhou Psychiatric Hospital
- Investigators
- Lin Kangguang, MD;PHD, Principal investigator, Guangzhou Psychiatric Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04633707
- Sponsor's protocol ID
- Guangzhou Brain Hospital BLT
- Status last verified
- Feb 2021
- First submitted
- 12 Nov 2020
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Bright Light Therapy for Patients With Depression at Different Time Period: A Randomized Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT04633707
- Acronym / sponsor ID
- Guangzhou Brain Hospital BLT
- Conditions
- Depressive Disorder, Light Therapy
- Keywords
- Depression, Bright Light Therapy, Time Period
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 159 participants (estimated)
- Lead sponsor
- Guangzhou Psychiatric HospitalOther government
- Study start
- Mar 2021 (estimated)
- Primary completion
- May 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 18 Nov 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.
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.
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.).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adjunctive morning BLT group | Experimental | Device: adjunctive bright white light therapy in the morningtreat participants with adjunctive BLT in the morning |
| Adjunctive afternoon BLT group | Experimental | Device: adjunctive bright white light therapy in the afternoontreat participants with adjunctive BLT in the afternoon |
| Adjunctive placebo therapy group | Placebo comparator | Device: adjunctive dim red light therapy in the afternoontreat participants with adjunctive dim red light in the afternoon |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 12-75 years old
- Diagnosed using DSM-5 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
Key exclusion criteria (6 listed)
- 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.)
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 |
|---|---|---|
| adjunctive bright white light therapy in the morningthe 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. | Device | Adjunctive morning BLT group |
| adjunctive bright white light therapy in the afternoonthe 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. | Device | Adjunctive afternoon BLT group |
| adjunctive dim red light therapy in the afternoonthe 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. | Device | Adjunctive placebo therapy group |
Primary outcome
response rate
Time frame: up to week 6
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.
3 secondary outcomes
manic/hypomanic conversion rate
Time frame: week 2; week 4; week 6
side effect
Time frame: week 2; week 4;week 6
sleep quality
Time frame: week 2; week 4;week 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Individual participant dataSharing planned: No
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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.
Lin Kangguang, MD;PHD principal investigator
Guangzhou Psychiatric Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing adjunctive bright white light therapy in the morning, adjunctive bright white light therapy in the afternoon and adjunctive dim red light therapy in the afternoon in people with Depressive Disorder and Light Therapy, run by Guangzhou Psychiatric Hospital at 1 site in China.
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 9 inclusion and 6 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 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Lin Kangguang, MD;PHD (13560360144 ext. 18028619981, linkangguang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response rate (time frame: up to week 6). 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 23 Mar 2021.