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Transcranial Laser Therapy, Continuous and Pulsed Light, for Major Depressive Disorder (ELATED-3) (ELATED-3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02959307
Recruitment Status : Completed
First Posted : November 9, 2016
Results First Posted : September 21, 2020
Last Update Posted : September 21, 2020
Sponsor:
Collaborator:
LiteCure LLC
Information provided by (Responsible Party):
Paolo Cassano, Massachusetts General Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Depression Major Depressive Disorder Device: Transcranial Light Therapy Device: Sham Transcranial Light Therapy Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Transcranial Continuous and Pulse Near-Infrared Light in Depression: a Placebo-Controlled Study (ELATED-3).
Study Start Date : November 2016
Actual Primary Completion Date : November 2018
Actual Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Transcranial Light Therapy
Transcranial light therapy penetrates the skin and brain using light energy and, the light energy may activate under-stimulated brain regions.
 Device: 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.
Other Name: Low Level Laser-Light Therapy, Photobiomodulation
Sham Comparator: 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
 Device: 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.
Other Name: Low Level Laser-Light Therapy, Photobiomodulation

Device: 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.
Other Name: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Quick Inventory of Depressive Symptomatology-Phase 1 [ Time Frame: 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.

  2. Quick Inventory of Depressive Symptomatology(QIDS)-Phase 2 [ Time Frame: 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 Outcome Measures :
  1. Hamilton Depression Rating Scale - 17 Items(Phase 1) [ Time Frame: 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.

  2. Hamilton Depression Rating Scale - 17 Items(Phase 2) [ Time Frame: 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02959307


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, New York
Nathan S. Kline Institute for Psychiatric Research
Orangeburg, New York, United States, 10962
Sponsors and Collaborators
Massachusetts General Hospital
LiteCure LLC
Investigators
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Principal Investigator: Paolo Cassano, M.D. Depression Clinical and Research Program
  Study Documents (Full-Text)

Documents provided by Paolo Cassano, Massachusetts General Hospital:
Study Protocol  [PDF] December 19, 2017
Informed Consent Form  [PDF] March 1, 2017
Statistical Analysis Plan  [PDF] May 12, 2020

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Paolo Cassano, Assistant Professor of Psychiatry, Harvard Medical School, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02959307    
Other Study ID Numbers: 2016P001490
First Posted: November 9, 2016    Key Record Dates
Results First Posted: September 21, 2020
Last Update Posted: September 21, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Personally unidentifiable information will be sent to Dr. Anastasia Ivanova, a privately contracted biostatistician form Chapel Hill North Carolina, for analyses. All information sent to Dr. Ivanova uses acrostics in place of personally identifiable information.
Keywords provided by Paolo Cassano, Massachusetts General Hospital:
Depression
Major Depressive Disorder
Major Depressive Episode
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
 Behavioral Symptoms
Mood Disorders
Mental Disorders