Adjunctive Bright Light Therapy for Patients With Depression

Study Overview
=================
Brief 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.

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.).

Official Title
-----------------
Adjunctive Bright Light Therapy for Patients With Depression at Different Time Period: A Randomized Double-Blind, Placebo-Controlled Trial

Conditions
-----------------
Depressive Disorder, Light Therapy

Intervention / Treatment
-----------------
* Device: adjunctive bright white light therapy in the morning
* Device: adjunctive bright white light therapy in the afternoon
* Device: adjunctive dim red light therapy in the afternoon


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adjunctive morning BLT group<br>treat participants with adjunctive BLT in the morning | Device: adjunctive bright white light therapy in the morning<br>* 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.<br>|
| Experimental: Adjunctive afternoon BLT group<br>treat participants with adjunctive BLT in the afternoon | Device: adjunctive bright white light therapy in the afternoon<br>* 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.<br>|
| Placebo Comparator: Adjunctive placebo therapy group<br>treat participants with adjunctive dim red light in the afternoon | Device: adjunctive dim red light therapy in the afternoon<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | week 2; week 4; week 6 | 
| side effect | record the possible adverse reactions | 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. | week 2; week 4;week 6 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Depression, Bright Light Therapy, Time Period