title: Transcranial bright light treatment via the ear canals in seasonal affective disorder: a randomized, double-blind dose-response study.
abstract: BACKGROUND
  Bright light treatment is effective for seasonal affective disorder (SAD), although the mechanisms of action are still unknown. We investigated whether transcranial bright light via the ear canals has an antidepressant effect in the treatment of SAD.
  
  
  METHODS
  During the four-week study period, 89 patients (67 females; 22 males, aged 22-65, mean ± SD age: 43.2 ± 10.9 years) suffering from SAD were randomized to receive a 12-min daily dose of photic energy of one of three intensities (1 lumen/0.72 mW/cm(2); 4 lumens/2.881 mW/cm(2); 9 lumens/6.482 mW/cm(2)) via the ear canals. The light was produced using light-emitting diodes. The severity of depressive symptoms was assessed with the Hamilton Depression Rating Scale - Seasonal Affective Disorder (SIGH-SAD), the Hamilton Anxiety Rating Scale (HAMA), and the Beck Depression Inventory (BDI). Cognitive performance was measured by the Trail Making Test (TMT). The within-group and between-group changes in these variables throughout the study were analysed with a repeated measures analysis of variance (ANOVA), whereas gender differences at baseline within the light groups were analysed using Student's t-tests.
  
  
  RESULTS
  Patients in all three groups showed significant decreases in their BDI, HAMA, and SIGH-SAD scores. Response rates, i.e., an at least 50% decrease of symptoms as measured by the BDI, were 74%-79% in the three treatment groups. Corresponding variations for the SIGH-SAD and the HAMA were 35-45% and 47-62%, respectively. No intensity-based dose-response relationships in the improvement of anxiety and depressive symptoms or cognitive performance between treatment groups were observed. Approximately one in four patients experienced mild adverse effects, of which the most common were headache, insomnia, and nausea.
  
  
  CONCLUSIONS
  These results suggests that transcranial bright light treatment may have antidepressant and anxiolytic effect in SAD patients, as both self- and psychiatrist-rated depressive and anxiety symptoms decreased in all treatment groups. These improvements are comparable to findings of earlier bright light studies that used conventional devices. The lack of dose response may be due to a saturation effect above a certain light intensity threshold. Further studies on the effects of transcranial bright light with an adequate placebo condition are needed.
  
  
  BACKGROUND
  NCT01293409, ClinicalTrials.gov.
authors.affiliation: Department of Psychiatry, University of Oulu, Institute of Clinical Medicine, Oulu, 90014, Finland. Heidi.Jurvelin@student.oulu.fi.
authors.forename: Heidi
authors.initials: H
authors.lastname: Jurvelin
authors.forename: Timo
authors.initials: T
authors.lastname: Takala
authors.forename: Juuso
authors.initials: J
authors.lastname: Nissilä
authors.forename: Markku
authors.initials: M
authors.lastname: Timonen
authors.forename: Melanie
authors.initials: M
authors.lastname: Rüger
authors.forename: Jari
authors.initials: J
authors.lastname: Jokelainen
authors.forename: Pirkko
authors.initials: P
authors.lastname: Räsänen
mesh_terms: D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D004424:Ear Canal; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010789:Phototherapy / Q000379:methods*; D011569:Psychiatric Status Rating Scales; D016574:Seasonal Affective Disorder / Q000628:therapy*; D016896:Treatment Outcome; D055815:Young Adult