Light Therapy on Major Depression Disorder

NCT ID: NCT03941301

Last Updated: 2022-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2020-06-30

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.

Conditions

Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Bright treatment light

Group Type: EXPERIMENTAL

Light therapy

Intervention Type: DEVICE

Participants will be exposed to bright treatment light or red light 30 minutes every day for 4 weeks.

Red light

Group Type: PLACEBO_COMPARATOR

Light therapy

Intervention Type: DEVICE

Participants will be exposed to bright treatment light or red light 30 minutes every day for 4 weeks.

Interventions

Light therapy

Participants will be exposed to bright treatment light or red light 30 minutes every day for 4 weeks.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Tsing Hua University,Taiwan

OTHER

Sponsor Role: collaborator

Ministry of Science and Technology, Taiwan

OTHER_GOV

Sponsor Role: collaborator

Mackay Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chun-Chao Huang

Role: PRINCIPAL_INVESTIGATOR

Mackay Memorial Hospital

Locations

Mackay Memorial Hospital

Taipei, , Taiwan

Countries

Taiwan

References

Huang CC, Huang HC, Lin CJ, Hsu CC, Lee CS, Hsu YH, Chen TL, Liao WH, Wu YH, Yang FG, Liu SI. Subclinical alterations of resting state functional brain network for adjunctive bright light therapy in nonseasonal major depressive disorder: A double blind randomized controlled trial. Front Neurol. 2022 Nov 9;13:979500. doi: 10.3389/fneur.2022.979500. eCollection 2022.

Reference Type: DERIVED

PMID: 36438959 (View on PubMed)

Other Identifiers

18MMHIS114e

Identifier Type: -

Identifier Source: org_study_id