- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03941301
Light Therapy on Major Depression Disorder
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:
- To investigate possible imaging biomarkers of major depression disorder
- To evaluate the effect of light therapy on depression
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:
- To evaluate the additional effect of the treatment light on depression disorder
- To compare the difference of functional magnetic resonance imaging(fMRI), structural MRI among the two groups and between the patients with and without treatment effect in order to detect imaging biomarkers.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Taipei, Taiwan, 10449
- Mackay Memorial Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Fulfill diagnosis of Major depression disorder based on Diagnostic and Statistical Manual of Mental Disorders(DSM-V) for at least 6 weeks and under medication treatment for at least 4 weeks.
- at least 20 years old
- Hamilton Depression Rating Scale(HAMD-17) >= 13
- No medication change for at least 4 weeks and no medication change will be considered in the next 8 weeks.
- Agree to participate in this study and sign the permit.
Exclusion Criteria:
- Seasonal depression disorder
- Other psychological or neurological disorder
- Drug or alcohol abuse within 30 days
- Visual problem
- Light-induced seizure or migraine
- Contraindication for MRI study
- Severe illness and might be admitted in the near future
- Might have a long trip in the near future
Study Plan
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: Bright treatment light
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Participants will be exposed to bright treatment light or red light 30 minutes every day for 4 weeks.
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Placebo Comparator: Red light
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Participants will be exposed to bright treatment light or red light 30 minutes every day for 4 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline Hamilton Depression Rating Scale(HAM-D) at 1,2,4,8 weeks
Time Frame: 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
Time Frame: 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.
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Change from Baseline Clinical Global Impression-Severity(CGI-S) at 1,2,4,8 weeks
Time Frame: 1,2,4,8 weeks.
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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:
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1,2,4,8 weeks.
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Change from Baseline Patient Health Questionnaire(PHQ-9) at 1,2,4,8 weeks
Time Frame: 1,2,4,8 weeks.
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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.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
functional MRI
Time Frame: 4 weeks
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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. |
4 weeks
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Diffusion Tensor Imaging of MRI
Time Frame: 4 weeks
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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
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Chun-Chao Huang, Mackay Memorial Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18MMHIS114e
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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