Light Therapy on Major Depression Disorder

NCT03941301 | Completed

• 1 other identifier: 18MMHIS114e
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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. 1.To investigate possible imaging biomarkers of major depression disorder
2. 2.To evaluate the effect of light therapy on depression
3. 3.To evaluate the additional effect of the treatment light on depression disorder
4. 4.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

Outcome Measures

Primary Outcomes (4)

• Change from Baseline Hamilton Depression Rating Scale(HAM-D) at 1,2,4,8 weeks

  Determine severity of depression (scores: 0-50) 1. Depressed Mood (sadness, hopeless, helpless, worthless) (0-4 scores) 2. Feelings of Guilt(0-4 scores) 3. Suicide(0-4 scores) 4. Insomnia - Early(0-2 scores) 5. Insomnia - Middle(0-2 scores) 6. Insomnia - Late(0-2 scores) 7. Work and Activities(0-4 scores) 8. Retardation (slowness of thought and speech; impaired ability to concentrate; decreased motor activity)(0-4 scores) 9. Agitation(0-2 scores) 10. Anxiety - Psychic(0-4 scores) 11. Anxiety - Somatic(0-4 scores) 12. Somatic Symptoms - Gastrointestinal(0-2 scores) 13. Somatic Symptoms - General(0-2 scores) 14. Genital Symptoms(0-2 scores) 15. Hypochondriasis(0-4 scores) 16. Loss of Weight(0-2 scores) 17. Insight(0-2 scores) 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.

  1,2,4,8 weeks.

• Change from Baseline Montgomery-Asberg Depression Rating Scale(MADRS) at 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 1\. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts 0 to 6 - normal /symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression \>34 - severe depression

  1,2,4,8 weeks.

• Change from Baseline Clinical Global Impression-Severity(CGI-S) at 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: 1. Normal, not at all ill 2. Borderline mentally ill 3. Mildly ill 4. Moderately ill 5. Markedly ill 6. Severely ill 7. Among the most extremely ill patients

  1,2,4,8 weeks.

• Change from Baseline Patient Health Questionnaire(PHQ-9) at 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 1. Little interest or pleasure in doing things 2. Feeling down, depressed, or hopeless 3. Trouble falling or staying asleep, or sleeping too much 4. Feeling tired or having little energy 5. Poor appetite or overeating 6. Feeling bad about yourself, or that you are a failure, or have let yourself or your family down 7. Trouble concentrating on things, such as reading the newspaper or watching television 8. Moving or speaking so slowly that other people could have noticed? Or the opposite, being so fidgety or restless that you have been moving around a lot more than usual 9. Thoughts that you would be better off dead or of hurting yourself in some way 0-4:No depression, 5-9:Mild, 10-14:Moderate, 15-19:Moderately severe, 20-27: Severe

  1,2,4,8 weeks.

Secondary Outcomes (2)

• functional MRI

  4 weeks

• Diffusion Tensor Imaging of MRI

  4 weeks

Study Arms (2)

Bright treatment light

EXPERIMENTAL

Device: Light therapy

Red light

PLACEBO COMPARATOR

Device: Light therapy

Interventions

Light therapy DEVICE

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

Bright treatment light; Red light

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Seasonal depression disorder
• Other psychological or neurological disorder
• Drug or alcohol abuse within 30 days
• Visual problem
• Light-induced seizure or migraine
• Contraindication for MRI study
• Severe illness and might be admitted in the near future
• Might have a long trip in the near future

Sponsors & Collaborators

• Mackay Memorial Hospital: lead
• National Tsing Hua University,Taiwan: collaborator
• Ministry of Science and Technology, Taiwan: collaborator

Study Sites (1)

Mackay Memorial Hospital

Taipei, 10449, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 36438959 DERIVED

MeSH Terms

Conditions

Depressive Disorder

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Chun-Chao Huang

  Mackay Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2019
• First Posted: May 7, 2019
• Study Start: June 1, 2019
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)