Transcranial Bright Light Therapy in Seasonal Affective Disorder (SAD)

Seasonal Affective Disorder (SAD) Clinical Trial

— SAD3  

Official title:

Transcranial Bright Light Therapy in Seasonal Affective Disorder (SAD)- a Randomized Placebo-controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01784705
• Other study ID #: VCT-003
• Status: Completed
• Phase: N/A
• First received: February 4, 2013
• Last updated: June 27, 2013
• Start date: January 2013
• Est. completion date: March 2013

Study information

• Verified date: June 2013
• Source: University of Oulu
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mood Disorders
• Seasonal Affective Disorder
• Seasonal Affective Disorder (SAD)

Intervention

Device:
• Transcranial bright light therapy
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.
• Transcranial placebo treatment
The placebo treatment was given transcranially via ear canals by placebo device. Daily 12 minutes placebo treatment was taken at home during forenoon.

Locations

Country	Name	City	State
Finland	Oulu University	Oulu

Sponsors (1)

Lead Sponsor	Collaborator
University of Oulu

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	At the end of the four week study period	No
Secondary	Beck Depression Inventory-II, total score <=10	Remission, i.e.,Beck Depression Inventory-II, total score <=10	At the end of the four week study period	No
Secondary	State Trait Anxiety Inventory -Y2, total score		At the end of the four week study period	No
Secondary	Trail- making test (TMT-A and TMT-B),total time		At the end of the four weeks study period	No