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Completed

NCT Number: NCT01293409

Bright Light Therapy in Seasonal Affective Disorder (SAD)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ODL Terveys Oy

Oulu, 90100, Finland

Who can participate

Healthy volunteers accepted: Yes

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

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, seasonal pattern, "moderate" or "severe" (classification code 296.32 and 296.33)

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

  • The 29-item Structured Interview Guide for Hamilton Depression Rating Scale - Seasonal Affective 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 criteria

  • patient has a lifetime psychotic disorder
  • patient has a DSM-IV Axis I disorder other than some anxiety disorder evaluated by MINI
  • patient has some DSM-IV-TR Axis II disorder, which is likely to interfere with the study 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

Treatment and study plan

Transcranial Brain-Targeted Bright Light Treatment

Other

Transcranial Brain-Targeted Bright Light Treatment via Ear Canals

Other names: VALKEE

Primary outcomes

  1. 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

    Remission, i.e., the 29-item Structured Interview Guide for Hamilton Depression Rating Scale - Seasonal Affective Disorder Version (SIGH-SAD) total score ≤ 8

Secondary outcomes

  1. ≥ 50 % decrease of the severity of symptoms as assessed by SIGH-SAD

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

  2. ≥ 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

  3. ≥ 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

  4. ≥ 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

  5. 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

Sponsors and collaborators

Lead sponsor

University of Oulu

Other

Collaborators

  • ODL Terveys Oy
  • Oulu University Hospital
  • University of Eastern Finland
  • Valkee Oy

Registry information

Official study title

Transcranial Brain-Targeted Bright Light Treatment Via Ear Canals in Seasonal Affective Disorder (SAD) - a Randomized Placebo Controlled Dose Finding Study

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 10, 2011
Registry last updated
Jun 1, 2011

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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