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| Name | Class |
|---|---|
| National Tsing Hua University,Taiwan | OTHER |
| Ministry of Science and Technology, Taiwan | OTHER_GOV |
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Background:
Major depression disorder is a common psychological disease. It is the second-ranked cause of disability worldwide. The pathophysiology is not yet understood. The main theory is monoaminergic theory based on the effect of monoaminergic drugs. Current treatment includes psychotherapy, medication and electroconvulsive therapy. The onset of action for antidepressant is often slow, therefore strategies to improve the outcome are important. Bright light therapy has been found to be effective in reducing the severity of depression not only in seasonal affective disorder but also in other affective disorder. Previous meta-analyses of light therapy for non-seasonal major depression, however, has yielded conflicting evidence for efficacy.
Purpose:
Materials and Methods:
This prospective study will recruit 100 patients, randomized into 2 study groups: (1) antidepressant plus treatment light, and (2) antidepressant plus placebo light. All patients will accept a thorough psychological evaluation (including Hamilton Depression Rating Scale, Montgomery-Asberg Depression Rating Scale, Clinical Global Impression-Severity and Patient Health Questionnaire-9 items) at baseline and at the 1st, 2nd, 4th, 8th week during the 8-week experiment intervention, by a blind assessor. Morningness- Eveningness Questionnaire-Self-Assessment Version (MEQ-SA) was only evaluated at baseline. Adverse events were evaluated at baseline, 2nd,4th,8th weeks. MRI study will be arranged at baseline and in 4-week experiment.
Predicted Results and Influence:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bright treatment light | Experimental |
| |
| Red light | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Light therapy | Device | Participants will be exposed to bright treatment light or red light 30 minutes every day for 4 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Hamilton Depression Rating Scale(HAM-D) at 1,2,4,8 weeks | Determine severity of depression (scores: 0-50)
Scores below 7 generally represent the absence or remission of depression. Scores between 7-17 represent mild depression. Scores between 18-24 represent moderate depression. Scores 25 and above represent severe depression. | 1,2,4,8 weeks. |
| Change from Baseline Montgomery-Asberg Depression Rating Scale(MADRS) at 1,2,4,8 weeks | Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The questionnaire includes questions on the following symptoms 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts 0 to 6 - normal /symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression | 1,2,4,8 weeks. |
| Change from Baseline Clinical Global Impression-Severity(CGI-S) at 1,2,4,8 weeks | The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Possible ratings are:
| 1,2,4,8 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| functional MRI | Compare brain resting-state functional MRI change between these two arms. Including measures brain activity by detecting changes associated with blood flow and difference of Resting State Network which is a functionally connected neural network of apparent brain states. Increased strength of the activities or resting state network indicates neural activities are elevated within the regions of the brain or the network. Decreased strength of the activities or resting state network indicates neural activities are diminished within the regions of the brain or the network. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chun-Chao Huang | Mackay Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mackay Memorial Hospital | Taipei | 10449 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36438959 | Derived | Huang CC, Huang HC, Lin CJ, Hsu CC, Lee CS, Hsu YH, Chen TL, Liao WH, Wu YH, Yang FG, Liu SI. Subclinical alterations of resting state functional brain network for adjunctive bright light therapy in nonseasonal major depressive disorder: A double blind randomized controlled trial. Front Neurol. 2022 Nov 9;13:979500. doi: 10.3389/fneur.2022.979500. eCollection 2022. |
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| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D010789 | Phototherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Change from Baseline Patient Health Questionnaire(PHQ-9) at 1,2,4,8 weeks | Depression screening by a nine-item in adults Over the last two weeks, how often have you been bothered by any of the following problems? (Scores: 0-27) 0:Not at all, 1:Several days, 2:More than half the days, 3:Nearly every day
0-4:No depression, 5-9:Mild, 10-14:Moderate, 15-19:Moderately severe, 20-27: Severe | 1,2,4,8 weeks. |
| 4 weeks |
| Diffusion Tensor Imaging of MRI | Compare brain Diffusion Tensor Imaging between these two arms. Evaluation the connection or fiber tracts between regions of the brain. Increased strength means enhanced connection between neuronal regions of the brain. Decreased strength means decreased connection between neuronal regions of the brain. | 4 weeks |