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Clinical Trial Summary

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:

1. To investigate possible imaging biomarkers of major depression disorder

2. 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 2nd, 4th, 8th week during the 8-week experiment intervention, by a blind assessor. Mini-International Neuropsychiatric Interview (MINI) and Morningness- Eveningness Questionnaire-Self-Assessment Version (MEQ-SA) were 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:

1. To evaluate the additional effect of the treatment light on depression disorder

2. 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03941301
Study type Interventional
Source Mackay Memorial Hospital
Contact Chun-Chao Huang
Phone 886-975835637
Email hcc.5306@mmh.org.tw
Status Not yet recruiting
Phase N/A
Start date May 2019
Completion date December 2019

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