Bright Light Therapy in Seasonal Affective Disorder (SAD)

Study Overview
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Brief Summary
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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.

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

Conditions
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Seasonal Affective Disorder

Intervention / Treatment
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* Other: Transcranial Brain-Targeted Bright Light Treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 | Measure Description | 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 |