Bright Light Therapy in Seasonal Affective Disorder (SAD)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-03-31

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.

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Detailed Description

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Conditions

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Seasonal Affective Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

The amount of photic energy of light is considered to be non-therapeutical

Group Type PLACEBO_COMPARATOR

Transcranial Brain-Targeted Bright Light Treatment

Intervention Type OTHER

Transcranial Brain-Targeted Bright Light Treatment via Ear Canals

Intermediate dose

The amount of photic energy of bright light is considered to be "intermediate"

Group Type EXPERIMENTAL

Transcranial Brain-Targeted Bright Light Treatment

Intervention Type OTHER

Transcranial Brain-Targeted Bright Light Treatment via Ear Canals

High dose bright light

The amount of photic energy of bright light is considered to be fully therapeutic

Group Type EXPERIMENTAL

Transcranial Brain-Targeted Bright Light Treatment

Intervention Type OTHER

Transcranial Brain-Targeted Bright Light Treatment via Ear Canals

Interventions

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Transcranial Brain-Targeted Bright Light Treatment

Transcranial Brain-Targeted Bright Light Treatment via Ear Canals

Intervention Type OTHER

Other Intervention Names

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VALKEE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes