Transcranial Laser Therapy, Continuous and Pulsed Light, for Major Depressive Disorder (ELATED-3)
Condition: Depression; Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

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.
    

Intervention name(s): Transcranial Light Therapy; Sham Transcranial Light Therapy
Intervention type(s): Device; Device
Intervention description(s): 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.; 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 intervention name(s): Low Level Laser-Light Therapy, Photobiomodulation; Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Depression; Major Depressive Disorder; Major Depressive Episode