Depressive DisorderNCT03941301
Light Therapy on Major Depression Disorder
A study testing Light therapy in people with Depressive Disorder, run by Mackay Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Depressive Disorder
- What is being tested?
- Light therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2019to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
Purpose:
- To investigate possible imaging biomarkers of major depression disorder
- 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:
- To evaluate the additional effect of the treatment light on depression disorder
- 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
- Being tested
- Light therapy
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light therapyDevice
Participants will be exposed to bright treatment light or red light 30 minutes every day for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Bright treatment light | Experimental | Not described Receives: Device: Light therapy |
| Red light | Placebo comparator | Not described Receives: Device: Light therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Hamilton Depression Rating Scale(HAM-D) at 1,2,4,8 weeks
Determine severity of depression (scores: 0-50)
- Depressed Mood (sadness, hopeless, helpless, worthless) (0-4 scores)
- Feelings of Guilt(0-4 scores)
- Suicide(0-4 scores)
- Insomnia - Early(0-2 scores)
- Insomnia - Middle(0-2 scores)
- Insomnia - Late(0-2 scores)
- Work and Activities(0-4 scores)
- Retardation (slowness of thought and speech; impaired ability to concentrate; decreased motor activity)(0-4 scores)
- Agitation(0-2 scores)
- Anxiety - Psychic(0-4 scores)
- Anxiety - Somatic(0-4 scores)
- Somatic Symptoms - Gastrointestinal(0-2 scores)
- Somatic Symptoms - General(0-2 scores)
- Genital Symptoms(0-2 scores)
- Hypochondriasis(0-4 scores)
- Loss of Weight(0-2 scores)
- 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.
Measured: 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
- 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
Measured: 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:
- Normal, not at all ill
- Borderline mentally ill
- Mildly ill
- Moderately ill
- Markedly ill
- Severely ill
- Among the most extremely ill patients
Measured: 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
- Little interest or pleasure in doing things
- Feeling down, depressed, or hopeless
- Trouble falling or staying asleep, or sleeping too much
- Feeling tired or having little energy
- Poor appetite or overeating
- Feeling bad about yourself, or that you are a failure, or have let yourself or your family down
- Trouble concentrating on things, such as reading the newspaper or watching television
- 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
- 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
Measured: 1,2,4,8 weeks.
Secondary outcomes (2)
functional MRI
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.
Measured: 4 weeks
Diffusion Tensor Imaging of MRI
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start1 Jun 2019
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Tsing Hua University,Taiwan, Ministry of Science and Technology, Taiwan
- Responsible party
- Sponsor
- Investigators
- Chun-Chao Huang, Principal investigator, Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03941301
- Sponsor's protocol ID
- 18MMHIS114e
- Status last verified
- Feb 2022
- First submitted
- 27 Mar 2019
- Last updated
- 2 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36438959
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Light Therapy on Major Depression Disorder
- ClinicalTrials.gov ID
- NCT03941301
- Acronym / sponsor ID
- 18MMHIS114e
- Conditions
- Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Collaborators
- National Tsing Hua University,Taiwan, Ministry of Science and Technology, Taiwan
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 7 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To investigate possible imaging biomarkers of major depression disorder
- 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:
- To evaluate the additional effect of the treatment light on depression disorder
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bright treatment light | Experimental | Device: Light therapy |
| Red light | Placebo comparator | Device: Light therapy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- Seasonal depression disorder
- Other psychological or neurological disorder
- Drug or alcohol abuse within 30 days
- Visual problem
- Light-induced seizure or migraine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Light therapyParticipants will be exposed to bright treatment light or red light 30 minutes every day for 4 weeks. | Device | Bright treatment light, Red light |
Primary outcome
Change from Baseline Hamilton Depression Rating Scale(HAM-D) at 1,2,4,8 weeks
Time frame: 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.
Change from Baseline Montgomery-Asberg Depression Rating Scale(MADRS) at 1,2,4,8 weeks
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 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
Change from Baseline Clinical Global Impression-Severity(CGI-S) at 1,2,4,8 weeks
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: 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
Change from Baseline Patient Health Questionnaire(PHQ-9) at 1,2,4,8 weeks
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 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
2 secondary outcomes
functional MRI
Time frame: 4 weeks
Diffusion Tensor Imaging of MRI
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Derived from this study: PubMed 36438959Huang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chun-Chao Huang principal investigator
Mackay Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Light therapy in people with Depressive Disorder, run by Mackay Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Hamilton Depression Rating Scale(HAM-D) at 1,2,4,8 weeks (time frame: 1,2,4,8 weeks.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03941301, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.