- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04633707
Adjunctive Bright Light Therapy for Patients With Depression
March 21, 2021 updated by: Kangguang Lin, Guangzhou Psychiatric Hospital
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.
Study Overview
Status
Unknown
Conditions
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 Type
Interventional
Enrollment (Anticipated)
159
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lin Kangguang, MD;PHD
- Phone Number: 18028619981 13560360144
- Email: linkangguang@163.com
Study Contact Backup
- Name: Liu Tao, MD
- Phone Number: 15017554527
- Email: liutaolp@163.com
Study Locations
-
-
Guangdong
-
Guanzhou, Guangdong, China, 510370
- Guangzhou Brain Hospital (Guangzhou Huiai Hospital)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 75 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- Right-handed
- Primary school education or above
- Sign informed consents after a full explanation of this study.
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Adjunctive morning BLT group
treat participants with adjunctive BLT 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.
|
Experimental: Adjunctive afternoon BLT group
treat participants with adjunctive BLT 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.
|
Placebo Comparator: Adjunctive placebo therapy group
treat participants with adjunctive dim red light 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
up to week 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
manic/hypomanic conversion rate
Time Frame: week 2; week 4; week 6
|
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.
|
week 2; week 4; week 6
|
side effect
Time Frame: week 2; week 4;week 6
|
record the possible adverse reactions
|
week 2; week 4;week 6
|
sleep quality
Time Frame: week 2; week 4;week 6
|
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.
|
week 2; week 4;week 6
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lin Kangguang, MD;PHD, Guangzhou Psychiatric Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
March 1, 2021
Primary Completion (Anticipated)
May 1, 2022
Study Completion (Anticipated)
July 1, 2022
Study Registration Dates
First Submitted
November 12, 2020
First Submitted That Met QC Criteria
November 17, 2020
First Posted (Actual)
November 18, 2020
Study Record Updates
Last Update Posted (Actual)
March 23, 2021
Last Update Submitted That Met QC Criteria
March 21, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Guangzhou Brain Hospital BLT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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