Light Therapy on Major Depression Disorder

Mackay Memorial Hospital

Status: Completed

Conditions: Depressive Disorder

Treatments: Device: Light therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03941301

18MMHIS114e

Details and patient eligibility

About

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.

Enrollment: 43 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.
2. at least 20 years old
3. Hamilton Depression Rating Scale(HAMD-17) >= 13
4. No medication change for at least 4 weeks and no medication change will be considered in the next 8 weeks.
5. Agree to participate in this study and sign the permit.

Exclusion criteria

1. Seasonal depression disorder
2. Other psychological or neurological disorder
3. Drug or alcohol abuse within 30 days
4. Visual problem
5. Light-induced seizure or migraine
6. Contraindication for MRI study
7. Severe illness and might be admitted in the near future
8. Might have a long trip in the near future

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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43 participants in 2 patient groups, including a placebo group

Bright treatment light

Experimental group

Treatment:

Device: Light therapy

Red light

Placebo Comparator group

Treatment:

Device: Light therapy