Bright Light Therapy in Seasonal Affective Disorder (SAD)

Last updated: May 30, 2011
Sponsor: University of Oulu
Overall Status: Completed

Phase

N/A

Condition

Affective Disorders

Depression

Mood Disorders

Treatment

N/A

Clinical Study ID

NCT01293409
FI (FWA00000190) 11/2008b
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

• a patient has (according to the Diagnostic and Statistical Manual of Mental Disorders,fourth edition, text revision [DSM-IV-TR]) a Major depression, recurrent episode, seasonalpattern, "moderate" or "severe" (classification code 296.32 and 296.33) The 29-item Structured Interview Guide for Hamilton Depression Rating Scale - SeasonalAffective Disorder Version (SIGH-SAD) score ≥ 20

  • The 29-item Structured Interview Guide for Hamilton Depression Rating Scale - SeasonalAffective Disorder Version (SIGH-SAD) score ≥ 20

  • The 21-item Hamilton Depression Rating Scale score ≥ 10

  • The 8-item atypical symptom score ≥ 5

  • patient is over 18 years

  • patient can read and understand the subject information sheet

  • patient has signed the informed consent form

  • patient is not pregnant

Exclusion

Exclusion Criteria:

  • patient has a lifetime psychotic disorder

  • patient has a DSM-IV Axis I disorder other than some anxiety disorder evaluated byMINI

  • patient has some DSM-IV-TR Axis II disorder, which is likely to interfere with thestudy treatment according to the investigator

  • patient has alcohol or some other substance use dependence or misuse

  • patients has some unstable somatic disorder

  • patient uses some psychotropic agencies

  • patient is, in the opinion of the investigator, unsuitable for any reason

  • patient is a member of the site personnel or their immediate families

  • patient has had bright light therapy via ear canals during the current episode

Study Design

Total Participants: 90
Study Start date:
November 01, 2010
Estimated Completion Date:
March 31, 2011

Connect with a study center

  • ODL Terveys Oy

    Oulu, 90100
    Finland

    Site Not Available

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