Bright light therapy (BLT) is widely accepted as first-line treatment of seasonal affective disorder (SAD). However, the mechanism of action of BLT is still widely unknown. On the other hand, in mammals, light penetrates the skull bone and reaches the brain, and extra ocular transcranial phototransduction has physiological influences such as changed reproductive cycles and increased brain serotonin levels. Therefore, the investigators run a randomized, placebo controlled, double blind, dose finding study on the putative effect of transcranial bright light in the treatment of SAD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
Transcranial Brain-Targeted Bright Light Treatment via Ear Canals
ODL Terveys Oy
Oulu, Finland
The 29-item Structured Interview Guide for Hamilton Depression Rating Scale - Seasonal Affective Disorder Version (SIGH-SAD) total score ≤ 8
Remission, i.e., the 29-item Structured Interview Guide for Hamilton Depression Rating Scale - Seasonal Affective Disorder Version (SIGH-SAD) total score ≤ 8
Time frame: At the end of the four-week study period
≥ 50 % decrease of the severity of symptoms as assessed by SIGH-SAD
Time frame: At the end of the four-week study period
≥ 50 % decrease of the severity of symptoms as assessed by the 14-item Hamilton Anxiety Rating Scale total score
Time frame: At the end of the four-week study period
≥ 50 % decrease of the severity of symptoms as assessed by the 21-item Beck depression Inventory (BDI-21) total score
Time frame: At the end of the four-week study period
≥ 50 % decrease of the severity of symptoms as assessed by 21-item Hamilton Depression Rating Scale total score
Time frame: At the end of the four-week study period
A number of participants with bright light therapy related (according to physician decision) adverse events as a measure of safety and tolerability
Time frame: During the four week study period
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