Bright Light Therapy in Seasonal Affective Disorder (SAD)

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

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 Overview

• Status: Completed
• Conditions: Seasonal Affective Disorder
• Intervention / Treatment: Other: Transcranial Brain-Targeted Bright Light Treatment

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Oulu, Finland, 90100
    • ODL Terveys Oy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; The amount of photic energy of light is considered to be non-therapeutical	Other: Transcranial Brain-Targeted Bright Light Treatment; Transcranial Brain-Targeted Bright Light Treatment via Ear Canals; Other Names: VALKEE
Experimental: Intermediate dose; The amount of photic energy of bright light is considered to be "intermediate"	Other: Transcranial Brain-Targeted Bright Light Treatment; Transcranial Brain-Targeted Bright Light Treatment via Ear Canals; Other Names: VALKEE
Experimental: High dose bright light; The amount of photic energy of bright light is considered to be fully therapeutic	Other: Transcranial Brain-Targeted Bright Light Treatment; Transcranial Brain-Targeted Bright Light Treatment via Ear Canals; Other Names: VALKEE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At the end of the four-week study period

Secondary Outcome Measures

Outcome Measure	Time Frame
≥ 50 % decrease of the severity of symptoms as assessed by SIGH-SAD	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	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	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	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	During the four week study period

Collaborators and Investigators

• Sponsor: University of Oulu
• Collaborators: Oulu University Hospital; University of Eastern Finland; ODL Terveys Oy; Valkee Oy
• Investigators: Principal Investigator: Pirkko Räsänen, M.D., Ph.D., PROFESSOR

Publications and helpful links

General Publications

• Jurvelin H, Takala T, Nissila J, Timonen M, Ruger M, Jokelainen J, Rasanen P. Transcranial bright light treatment via the ear canals in seasonal affective disorder: a randomized, double-blind dose-response study. BMC Psychiatry. 2014 Oct 21;14:288. doi: 10.1186/s12888-014-0288-6.

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: January 21, 2011
• First Submitted That Met QC Criteria: February 9, 2011
• First Posted (Estimate): February 10, 2011

Study Record Updates

• Last Update Posted (Estimate): June 1, 2011
• Last Update Submitted That Met QC Criteria: May 30, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Depressive Disorder; Mood Disorders; Seasonal Affective Disorder
• Other Study ID Numbers: FI (FWA00000190) 11/2008b