Mackay Memorial Hospital
Taipei, 10449, Taiwan
NCT Number: NCT03941301
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 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:
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.
Looking for future studies?
Notify Me20 year and older
All sexes
Interventional
Not applicable
Taipei, 10449, Taiwan
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will be exposed to bright treatment light or red light 30 minutes every day for 4 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.
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
0 to 6 - normal /symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression
Time frame: 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:
Time frame: 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
Time frame: 4 weeks
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.
Time frame: 4 weeks
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.
Mackay Memorial Hospital
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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