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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.
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.).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adjunctive morning BLT group | Experimental | treat participants with adjunctive BLT in the morning |
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| Adjunctive afternoon BLT group | Experimental | treat participants with adjunctive BLT in the afternoon |
|
| Adjunctive placebo therapy group | Placebo Comparator | treat participants with adjunctive dim red light in the afternoon |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adjunctive bright white light therapy in the morning | Device | 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. |
| 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 severityï¼›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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lin Kangguang, MD;PHD | Contact | 13560360144 | 18028619981 | linkangguang@163.com |
| Liu Tao, MD | Contact | 15017554527 | liutaolp@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Lin Kangguang, MD;PHD | Guangzhou Psychiatric Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangzhou Brain Hospital (Guangzhou Huiai Hospital) | Guanzhou | Guangdong | 510370 | China |
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| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D003863 | Depression |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| adjunctive bright white light therapy in the afternoon | Device | 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 afternoon | Device | 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. |
|
| 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 |