Clinical trial NCT03941301: Light Therapy on Major Depression Disorder
Official title: Light Therapy on Major Depression Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Disorder
Lead sponsor: Mackay Memorial Hospital
Sponsor class: OTHER
Collaborators: name: National Tsing Hua University,Taiwan
name: Ministry of Science and Technology, Taiwan
First posted: 2019-05-07
Enrollment: 43
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline Hamilton Depression Rating Scale(HAM-D) at 1,2,4,8 weeks
timeFrame: 1,2,4,8 weeks.
measure: Change from Baseline Montgomery-Asberg Depression Rating Scale(MADRS) at 1,2,4,8 weeks
timeFrame: 1,2,4,8 weeks.
measure: Change from Baseline Clinical Global Impression-Severity(CGI-S) at 1,2,4,8 weeks
timeFrame: 1,2,4,8 weeks.
measure: Change from Baseline Patient Health Questionnaire(PHQ-9) at 1,2,4,8 weeks
timeFrame: 1,2,4,8 weeks.
Secondary outcomes:
measure: functional MRI
timeFrame: 4 weeks
measure: Diffusion Tensor Imaging of MRI
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
Study officials:
affiliation: Mackay Memorial Hospital
name: Chun-Chao Huang
role: PRINCIPAL_INVESTIGATOR
References: