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

NCT02959307 | Completed Results

• 1 other identifier: 2016P001490
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 2

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.

Conditions

Depression; Major Depressive Disorder

Keywords

Depression; Major Depressive Disorder; Major Depressive Episode

Outcome Measures

Primary Outcomes (2)

• 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.

  6 weeks - Sequential-parallel comparison design

• 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.

  6 weeks - Sequential-parallel comparison design

Secondary Outcomes (2)

• Hamilton Depression Rating Scale - 17 Items(Phase 1)

  6 weeks - Sequential-parallel comparison design

• Hamilton Depression Rating Scale - 17 Items(Phase 2)

  6 weeks - Sequential-parallel comparison design

Study Arms (2)

Transcranial Light Therapy

EXPERIMENTAL

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

Sham Transcranial Light Therapy

SHAM COMPARATOR

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; Device: Sham Transcranial Light Therapy

Interventions

Transcranial Light Therapy DEVICE

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.

Also known as: Low Level Laser-Light Therapy, Photobiomodulation

Sham Transcranial Light Therapy; Transcranial Light Therapy

Sham Transcranial Light Therapy DEVICE

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.

Also known as: Placebo

Sham Transcranial Light Therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• LiteCure LLC: collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Nathan S. Kline Institute for Psychiatric Research

Orangeburg, New York, 10962, United States

Location

Related Publications (1)

• 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.

  PMID: 35950904 DERIVED

MeSH Terms

Conditions

Depression; Depressive Disorder, Major

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Limitations and Caveats

For the device utilized in this trial, very low light was applied. In addition, two nodes were obstructed by participants' hair, reducing light delivered.

Results Point of Contact

• Title: Dr. Paolo Cassano
• Organization: Massachusetts General Hospital

pcassano@mgh.harvard.edu

617-643-9622

Study Officials

• Paolo Cassano, M.D.

  Depression Clinical and Research Program

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry, Harvard Medical School

Study Record Dates

• First Submitted: November 7, 2016
• First Posted: November 9, 2016
• Study Start: November 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: September 21, 2020
• Results First Posted: September 21, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share

Locations

US (2)