Transcranial Bright Light Therapy in Seasonal Affective Disorder (SAD) (SAD3)
Primary Purpose
Seasonal Affective Disorder (SAD)
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Transcranial bright light therapy
Transcranial placebo treatment
Sponsored by
About this trial
This is an interventional treatment trial for Seasonal Affective Disorder (SAD)
Eligibility Criteria
Inclusion Criteria:
- 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
- Structured Interview Guide for the Hamilton Depression Rating Scale - Seasonal Affective Disorder Version Self Rating Version (SIGH-SAD-SR) score ≥ 16
- patient is over 18 years and under 66 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 bipolar disorder
- patient has alcohol or some other substance use dependence or misuse
- patient 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 administered bright light therapy via ear canals during the current episode
Sites / Locations
- Oulu University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Transcranial bright light therapy
Transcranial placebo treatment
Arm Description
Outcomes
Primary Outcome Measures
Structured Interview Guide for the Hamilton Depression Rating Scale - Seasonal Affective Disorder Version Self Rating Version, total score ≤9
Remission, i.e., Structured Interview Guide for the Hamilton Depression Rating Scale - Seasonal Affective Disorder Version Self Rating Version total score ≤ 9
Secondary Outcome Measures
Beck Depression Inventory-II, total score <=10
Remission, i.e.,Beck Depression Inventory-II, total score <=10
State Trait Anxiety Inventory -Y2, total score
Trail- making test (TMT-A and TMT-B),total time
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01784705
Brief Title
Transcranial Bright Light Therapy in Seasonal Affective Disorder (SAD)
Acronym
SAD3
Official Title
Transcranial Bright Light Therapy in Seasonal Affective Disorder (SAD)- a Randomized Placebo-controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oulu
4. Oversight
5. Study Description
Brief Summary
Bright light therapy (BLT) has been found to be effective in treatment of seasonal affective disorder (SAD). The mechanism of action of conventional BLT in the treatment of SAD is under debate. Recently, transcranial bright light (TBL) via ear canals has been proved to modulate the neural networks of the human brain and improve cognitive performance in healthy subjects. Moreover, TBL has been found to alleviate symptoms of SAD in open trial. In this case the investigators will study the effect of transcranial bright light treatment via ear canals on depressive and anxiety symptoms in patients suffering from SAD in randomized controlled double-blind study design.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Affective Disorder (SAD)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transcranial bright light therapy
Arm Type
Experimental
Arm Title
Transcranial placebo treatment
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
Transcranial bright light therapy
Intervention Description
The bright light treatment was given transcranially via ear canals by using bright light device. The bright light was produced using two light-emitting diodes (LEDs). The bright light was transmitted into both ear canals by an optical fibre. Daily 12 minutes TBL was taken at home during forenoon.
Intervention Type
Device
Intervention Name(s)
Transcranial placebo treatment
Intervention Description
The placebo treatment was given transcranially via ear canals by placebo device. Daily 12 minutes placebo treatment was taken at home during forenoon.
Primary Outcome Measure Information:
Title
Structured Interview Guide for the Hamilton Depression Rating Scale - Seasonal Affective Disorder Version Self Rating Version, total score ≤9
Description
Remission, i.e., Structured Interview Guide for the Hamilton Depression Rating Scale - Seasonal Affective Disorder Version Self Rating Version total score ≤ 9
Time Frame
At the end of the four week study period
Secondary Outcome Measure Information:
Title
Beck Depression Inventory-II, total score <=10
Description
Remission, i.e.,Beck Depression Inventory-II, total score <=10
Time Frame
At the end of the four week study period
Title
State Trait Anxiety Inventory -Y2, total score
Time Frame
At the end of the four week study period
Title
Trail- making test (TMT-A and TMT-B),total time
Time Frame
At the end of the four weeks study period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Structured Interview Guide for the Hamilton Depression Rating Scale - Seasonal Affective Disorder Version Self Rating Version (SIGH-SAD-SR) score ≥ 16
patient is over 18 years and under 66 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 bipolar disorder
patient has alcohol or some other substance use dependence or misuse
patient 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 administered bright light therapy via ear canals during the current episode
Facility Information:
Facility Name
Oulu University
City
Oulu
ZIP/Postal Code
Box 5000, 90014
Country
Finland
12. IPD Sharing Statement
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Transcranial Bright Light Therapy in Seasonal Affective Disorder (SAD)
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