Bright Light Therapy in Seasonal Affective Disorder (SAD)

Not Applicable

Completed

• Conditions: Seasonal Affective Disorder
• Interventions: Other: Transcranial Brain-Targeted Bright Light Treatment

• Registration Number: NCT01293409
• Lead Sponsor: University of Oulu

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2011-01-21
• Study First Submitted QC: 2011-02-09
• Study First Posted: 2011-02-10
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-30
• Last Update Posted: 2011-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Transcranial Brain-Targeted Bright Light Treatment	The amount of photic energy of light is considered to be non-therapeutical
Intermediate dose	Transcranial Brain-Targeted Bright Light Treatment	The amount of photic energy of bright light is considered to be "intermediate"
High dose bright light	Transcranial Brain-Targeted Bright Light Treatment	The amount of photic energy of bright light is considered to be fully therapeutic

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
≥ 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

Trial Locations

Locations (1)

ODL Terveys Oy; 🇫🇮 Oulu, Finland