Transcranial Bright Light Therapy in Seasonal Affective Disorder (SAD)

NCT01784705 | Completed

• 1 other identifier: VCT-003
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Seasonal Affective Disorder (SAD)

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Beck Depression Inventory-II, total score <=10

  At the end of the four week study period

• State Trait Anxiety Inventory -Y2, total score

  At the end of the four week study period

• Trail- making test (TMT-A and TMT-B),total time

  At the end of the four weeks study period

Study Arms (2)

Transcranial bright light therapy

EXPERIMENTAL

Device: Transcranial bright light therapy

Transcranial placebo treatment

PLACEBO COMPARATOR

Device: Transcranial placebo treatment

Interventions

Transcranial bright light therapy DEVICE

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 bright light therapy

Transcranial placebo treatment DEVICE

The placebo treatment was given transcranially via ear canals by placebo device. Daily 12 minutes placebo treatment was taken at home during forenoon.

Transcranial placebo treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oulu: lead

Study Sites (1)

Oulu University

Oulu, Box 5000, 90014, Finland

Location

MeSH Terms

Conditions

Seasonal Affective Disorder

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research coordinator

Study Record Dates

• First Submitted: February 4, 2013
• First Posted: February 6, 2013
• Study Start: January 1, 2013
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: June 28, 2013

Record last verified: 2013-06

Locations

FI (1)