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NCT Number: NCT01784705

Transcranial Bright Light Therapy in Seasonal Affective Disorder (SAD)

Bright light therapy (BLT) has been found to be effective in treatment of seasonal affective disorder (SAD). The mechanism of action of conventional BLT in the treatment of SAD is under debate. Recently, transcranial bright light (TBL) via ear canals has been proved to modulate the neural networks of the human brain and improve cognitive performance in healthy subjects. Moreover, TBL has been found to alleviate symptoms of SAD in open trial. In this case the investigators will study the effect of transcranial bright light treatment via ear canals on depressive and anxiety symptoms in patients suffering from SAD in randomized controlled double-blind study design.

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Key information

Conditions

Seasonal Affective Disorder (SAD) Depressive Disorder Mental Disorders Mood Disorders Seasonal Affective Disorder

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oulu University

Oulu, Box 5000, 90014, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patient has (according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision [DSM-IV-TR]) a Major depression, recurrent episode, seasonal pattern
  • Structured Interview Guide for the Hamilton Depression Rating Scale - Seasonal Affective Disorder Version Self Rating Version (SIGH-SAD-SR) score ≥ 16
  • patient is over 18 years and under 66 years
  • patient can read and understand the subject information sheet
  • patient has signed the informed consent form
  • patient is not pregnant

Exclusion criteria

  • patient has a lifetime psychotic disorder
  • patient has a bipolar disorder
  • patient has alcohol or some other substance use dependence or misuse
  • patient 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 administered bright light therapy via ear canals during the current episode

Treatment and study plan

Transcranial bright light therapy

Device

The bright light treatment was given transcranially via ear canals by using bright light device. The bright light was produced using two light-emitting diodes (LEDs). The bright light was transmitted into both ear canals by an optical fibre. Daily 12 minutes TBL was taken at home during forenoon.

Transcranial placebo treatment

Device

The placebo treatment was given transcranially via ear canals by placebo device. Daily 12 minutes placebo treatment was taken at home during forenoon.

Primary outcomes

  1. Structured Interview Guide for the Hamilton Depression Rating Scale - Seasonal Affective Disorder Version Self Rating Version, total score ≤9

    Time frame: At the end of the four week study period

    Remission, i.e., Structured Interview Guide for the Hamilton Depression Rating Scale - Seasonal Affective Disorder Version Self Rating Version total score ≤ 9

Secondary outcomes

  1. Beck Depression Inventory-II, total score <=10

    Time frame: At the end of the four week study period

    Remission, i.e.,Beck Depression Inventory-II, total score <=10

  2. State Trait Anxiety Inventory -Y2, total score

    Time frame: At the end of the four week study period

  3. Trail- making test (TMT-A and TMT-B),total time

    Time frame: At the end of the four weeks study period

Sponsors and collaborators

Lead sponsor

University of Oulu

Other

Registry information

Official study title

Transcranial Bright Light Therapy in Seasonal Affective Disorder (SAD)- a Randomized Placebo-controlled Trial

Acronym: SAD3

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 6, 2013
Registry last updated
Jun 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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