Depression, Major Depressive Disorder
Conditions
Keywords
Depression, Major Depressive Disorder, Major Depressive Episode
Brief summary
Transcranial Light Therapy involves non-invasive and invisible beams of light that increase energy metabolism in the brain. Transcranial light therapy has been found to promote brain metabolism which may help people with depression. The research team proposes a novel approach to treating depression by using transcranial light therapy.
Detailed description
During study visits a clinician applies transcranial light therapy to both sides of a participant's forehead for about 30 minutes. The study involves, 1 screening visit which may last up to the 3 hours, 24 transcranial light therapy treatment visits, and 1 post-treatment visit (26 total visits to the Massachusetts General Hospital). If a participant qualifies for the study, we assign the participant by chance to receive either active transcranial light therapy or sham transcranial light therapy treatment. During sham transcranial light therapy visits, the transcranial light therapy device will not produce near infrared waves (e.g., light energy that cannot penetrate the skin and cranium). Participants have an equal chance of being assigned to the active transcranial light therapy or the sham transcranial light therapy when first randomized. Neither the participant, nor the clinician, nor any research staff will know which study group the participant belongs. Participants are randomized a second time after 6-weeks in the study. If the participant were in the sham group the first 6-weeks, that participant may receive the active transcranial light therapy treatment after re-randomization. If the participant were already in the active transcranial light therapy group during the first 6-weeks the participant continues receiving the active treatment. All in all, participants have a 1 in 3 chance of receiving the active transcranial light therapy treatment at some point during the study.
Interventions
Transcranial light therapy penetrates the skin and brain using light energy; this makes transcranial light therapy noninvasive. Transcranial light therapy may activate under-stimulated brain regions.
DEVICESham Transcranial Light Therapy
The same device used for the actual transcranial light therapy is used as the sham device; The device, when set to sham, will mimic the actual transcranial light therapy; however, when set to sham the device does not emit skin and cranium penetrating light emitting diode light energy.
Sponsors
LiteCure LLC
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Participant age at screening will be between (\>=)18 and 70 years old (inclusive). * Participant meets the criteria for major depressive disorder * Participants informed consent obtained in writing * Participant is available to participate in the study for at least 12 weeks
Exclusion criteria
* Significant skin conditions near the application site * Any use of light-activated drugs (photodynamic therapy) within 14 days prior to study enrollment * Recent history of stroke * The participant failed more than 2 adequate treatment with Federal Drug Administration approved antidepressants during current episode per antidepressant treatment response questionnaire criteria (less than 50% decrease in depressive symptomatology). * Structured psychotherapy focused on treating the subject's depression (i.e. cognitive behavioral therapy or interpersonal therapy) is permitted if started at least 8 weeks prior to the screening visit. * Substance dependence or abuse in the past 3 months. * History of a psychotic disorder or psychotic episode (current psychotic episode per M.I.N.I neuro-psychiatric assessment). * Bipolar affective disorder (per M.I.N.I neuro-psychiatric assessment). * Unstable medical illness, defined as any medical illness which is not well-controlled with standard-of-care medications (e.g., insulin for diabetes mellitus, hydrochlorothiazide for hypertension). * Active suicidal or homicidal ideation (both intention and plan are present), as determined by Columbia Suicide Severity Rating Scale * Cognitive impairment (Montreal Cognitive Assessment \<21) * The participant has a significant skin condition (i.e., hemangioma, scleroderma, psoriasis, rash, open wound or tattoo) on the subject's scalp that is found to be in proximity to any of the procedure sites. * The subject has an implant of any kind in the head (e.g. stent, clipped aneurysm, embolised arteriovenous malformation, implantable shunt - Hakim valve). * Any use of light-activated drugs (photodynamic therapy) within 14 days prior to study enrollment (in US: Visudyne (verteporfin) - for age related macular degeneration; Aminolevulinic Acid- for actinic keratoses; Photofrin (porfimer sodium) - for esophageal cancer, non-small cell lung cancer; Levulan Kerastick (aminolevulinic acid hydrogen chloride) - for actinic keratosis; 5-aminolevulinic acid for non-melanoma skin cancer) * Women of child-bearing potential must use a double-barrier method for birth control (e.g. condoms plus spermicide) if sexually active.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quick Inventory of Depressive Symptomatology-Phase 1 | 6 weeks - Sequential-parallel comparison design | This is a brief (16-item) clinician-rated inventory of core depressive symptoms such as sleep, depressed mood, appetite, concentration, suicidal ideation, interest, energy, psychomotor retardation or agitation. Scores range from 0-27, higher scores indicating greater depression severity. |
| Quick Inventory of Depressive Symptomatology(QIDS)-Phase 2 | 6 weeks - Sequential-parallel comparison design | This is a brief (16-item) clinician-rated inventory of core depressive symptoms such as sleep, depressed mood, appetite, concentration, suicidal ideation, interest, energy, psychomotor retardation or agitation. Scores range from 0-27, higher scores indicating greater depression severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Depression Rating Scale - 17 Items(Phase 1) | 6 weeks - Sequential-parallel comparison design | assessment of the patient's depressive symptoms, using a structured interview and defined anchor points. The Hamilton Depression Rating Scale aims to quantify the degree of depression in patients who already have a diagnosis of major depression. Score ranges from 0-52. Higher score indicates greater severity of depression. |
| Hamilton Depression Rating Scale - 17 Items(Phase 2) | 6 weeks - Sequential-parallel comparison design | assessment of the patient's depressive symptoms, using a structured interview and defined anchor points. The Hamilton Depression Rating Scale aims to quantify the degree of depression in patients who already have a diagnosis of major depression. Score ranges from 0-52. Higher score indicates greater severity of depression. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Transcranial Light Therapy Transcranial light therapy penetrates the skin and brain using light energy and, the light energy may activate under-stimulated brain regions.
Transcranial Light Therapy: Transcranial light therapy penetrates the skin and brain using light energy; this makes transcranial light therapy noninvasive. Transcranial light therapy may activate under-stimulated brain regions. | 18 |
| Sham Transcranial Light Therapy For the sham group, The transcranial light therapy device uses nonpenetrating light emitting diode light energy. The sham controls for which participants improve from the actual transcranial light therapy treatment and which participants improve during the study for reasons other than the therapy
Transcranial Light Therapy: Transcranial light therapy penetrates the skin and brain using light energy; this makes transcranial light therapy noninvasive. Transcranial light therapy may activate under-stimulated brain regions.
Sham Transcranial Light Therapy: The same device used for the actual transcranial light therapy is used as the sham device; The device, when set to sham, will mimic the actual transcranial light therapy; however, when set to sham the device does not emit skin and cranium penetrating light emitting diode light energy. | 31 |
| Total | 49 |
Baseline characteristics
| Characteristic | Transcranial Light Therapy | Sham Transcranial Light Therapy | Total |
|---|---|---|---|
| Age, Continuous | 37.222 years STANDARD_DEVIATION 15.509 | 42.806 years STANDARD_DEVIATION 15.823 | 40.755 years STANDARD_DEVIATION 16.137 |
| Age of Depressive Onset | 17.294 years STANDARD_DEVIATION 9.973 | 23.429 years STANDARD_DEVIATION 16.089 | 21.111 years STANDARD_DEVIATION 14.285 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 25 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 13 Participants | 27 Participants | 40 Participants |
| Sex: Female, Male Female | 14 Participants | 21 Participants | 35 Participants |
| Sex: Female, Male Male | 4 Participants | 10 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 31 |
| other Total, other adverse events | 12 / 31 | 17 / 31 |
| serious Total, serious adverse events | 0 / 31 | 1 / 31 |
Outcome results
Primary
Quick Inventory of Depressive Symptomatology-Phase 1
This is a brief (16-item) clinician-rated inventory of core depressive symptoms such as sleep, depressed mood, appetite, concentration, suicidal ideation, interest, energy, psychomotor retardation or agitation. Scores range from 0-27, higher scores indicating greater depression severity.
Time frame: 6 weeks - Sequential-parallel comparison design
Population: Sham Group in Phase 1 accounts for all subjects Receiving Sham. Patients in Sham within the first phase would be re-randomized to either NIR or Sham after completion of the initial 6 weeks. 2 participants in Sham did not have scores collected, as such the Sham group for Phase 1 consists of 29 participants rather than the total 31.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transcranial Light Therapy | Quick Inventory of Depressive Symptomatology-Phase 1 | 11.06 score on a scale | Standard Deviation 3.78 |
| Sham Transcranial Light Therapy | Quick Inventory of Depressive Symptomatology-Phase 1 | 11.24 score on a scale | Standard Deviation 4.83 |
Primary
Quick Inventory of Depressive Symptomatology(QIDS)-Phase 2
This is a brief (16-item) clinician-rated inventory of core depressive symptoms such as sleep, depressed mood, appetite, concentration, suicidal ideation, interest, energy, psychomotor retardation or agitation. Scores range from 0-27, higher scores indicating greater depression severity.
Time frame: 6 weeks - Sequential-parallel comparison design
Population: This group consists of all sham participants that did not respond to Sham in Phase 1 and were re-randomized into Phase 2. Therefore, of the 29 participants in Sham, 5 participants were responders, 4 were not re-randomized.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transcranial Light Therapy | Quick Inventory of Depressive Symptomatology(QIDS)-Phase 2 | 10.45 score on a scale | Standard Deviation 5.751 |
| Sham Transcranial Light Therapy | Quick Inventory of Depressive Symptomatology(QIDS)-Phase 2 | 9.14 score on a scale | Standard Deviation 5.551 |
Secondary
Hamilton Depression Rating Scale - 17 Items(Phase 1)
assessment of the patient's depressive symptoms, using a structured interview and defined anchor points. The Hamilton Depression Rating Scale aims to quantify the degree of depression in patients who already have a diagnosis of major depression. Score ranges from 0-52. Higher score indicates greater severity of depression.
Time frame: 6 weeks - Sequential-parallel comparison design
Population: Patients in Sham within the first phase would be re-randomized to either NIR or Sham after completion of the initial 6 weeks. There were two participants in the Sham group who did not have scores for the primary analysis (QIDS), we decided to include them in the secondary analysis (HAMD) as they had scores.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transcranial Light Therapy | Hamilton Depression Rating Scale - 17 Items(Phase 1) | 16.28 score on a scale | Standard Deviation 5.345 |
| Sham Transcranial Light Therapy | Hamilton Depression Rating Scale - 17 Items(Phase 1) | 15.81 score on a scale | Standard Deviation 6.685 |
Secondary
Hamilton Depression Rating Scale - 17 Items(Phase 2)
assessment of the patient's depressive symptoms, using a structured interview and defined anchor points. The Hamilton Depression Rating Scale aims to quantify the degree of depression in patients who already have a diagnosis of major depression. Score ranges from 0-52. Higher score indicates greater severity of depression.
Time frame: 6 weeks - Sequential-parallel comparison design
Population: This group consists of all sham participants that did not respond to Sham in Phase 1 and were re-randomized into Phase 2. Therefore, of the 29 participants in Sham, 5 participants were responders, 4 were not re-randomized. 1 participant was not assessed with HAMD but was assessed with primary measure (QIDS), as such there are 10 in TLT group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transcranial Light Therapy | Hamilton Depression Rating Scale - 17 Items(Phase 2) | 13.50 score on a scale | Standard Deviation 6.151 |
| Sham Transcranial Light Therapy | Hamilton Depression Rating Scale - 17 Items(Phase 2) | 14.14 score on a scale | Standard Deviation 6.768 |