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

Primary Purpose

Depression, Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Light Therapy
Sham Transcranial Light Therapy
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, Major Depressive Disorder, Major Depressive Episode

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Massachusetts General Hospital
  • Nathan S. Kline Institute for Psychiatric Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Transcranial Light Therapy

Sham Transcranial Light Therapy

Arm Description

Transcranial light therapy penetrates the skin and brain using light energy and, the light energy may activate under-stimulated brain regions.

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
November 7, 2016
Last Updated
August 31, 2020
Sponsor
Massachusetts General Hospital
Collaborators
LiteCure LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02959307
Brief Title
Transcranial Laser Therapy, Continuous and Pulsed Light, for Major Depressive Disorder (ELATED-3)
Acronym
ELATED-3
Official Title
Transcranial Continuous and Pulse Near-Infrared Light in Depression: a Placebo-Controlled Study (ELATED-3).
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
November 2018 (Actual)
Study Completion Date
November 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
LiteCure LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Major Depressive Disorder
Keywords
Depression, Major Depressive Disorder, Major Depressive Episode

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transcranial Light Therapy
Arm Type
Experimental
Arm Description
Transcranial light therapy penetrates the skin and brain using light energy and, the light energy may activate under-stimulated brain regions.
Arm Title
Sham Transcranial Light Therapy
Arm Type
Sham Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Transcranial Light Therapy
Other Intervention Name(s)
Low Level Laser-Light Therapy, Photobiomodulation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham Transcranial Light Therapy
Other Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quick Inventory of Depressive Symptomatology-Phase 1
Description
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
Title
Quick Inventory of Depressive Symptomatology(QIDS)-Phase 2
Description
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
Secondary Outcome Measure Information:
Title
Hamilton Depression Rating Scale - 17 Items(Phase 1)
Description
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
Title
Hamilton Depression Rating Scale - 17 Items(Phase 2)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paolo Cassano, M.D.
Organizational Affiliation
Depression Clinical and Research Program
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Nathan S. Kline Institute for Psychiatric Research
City
Orangeburg
State/Province
New York
ZIP/Postal Code
10962
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
35950904
Citation
Iosifescu DV, Norton RJ, Tural U, Mischoulon D, Collins K, McDonald E, De Taboada L, Foster S, Cusin C, Yeung A, Clain A, Schoenfeld D, Hamblin MR, Cassano P. Very Low-Level Transcranial Photobiomodulation for Major Depressive Disorder: The ELATED-3 Multicenter, Randomized, Sham-Controlled Trial. J Clin Psychiatry. 2022 Aug 8;83(5):21m14226. doi: 10.4088/JCP.21m14226.
Results Reference
derived

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

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