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Transcranial Bright Light Therapy in Seasonal Affective Disorder (SAD) (SAD3)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Heidi Jurvelin, University of Oulu
ClinicalTrials.gov Identifier:
NCT01784705
First received: February 4, 2013
Last updated: June 27, 2013
Last verified: June 2013
  Purpose
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.

Condition Intervention
Seasonal Affective Disorder (SAD)
Device: Transcranial bright light therapy
Device: Transcranial placebo treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcranial Bright Light Therapy in Seasonal Affective Disorder (SAD)- a Randomized Placebo-controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Oulu:

Primary Outcome Measures:
  • 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 ]
    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 [ Time Frame: At the end of the four week study period ]
    Remission, i.e.,Beck Depression Inventory-II, total score <=10

  • State Trait Anxiety Inventory -Y2, total score [ Time Frame: At the end of the four week study period ]
  • Trail- making test (TMT-A and TMT-B),total time [ Time Frame: At the end of the four weeks study period ]

Enrollment: 60
Study Start Date: January 2013
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Transcranial bright light therapy 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.
Placebo Comparator: Transcranial placebo treatment Device: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01784705

Locations
Finland
Oulu University
Oulu, Finland, Box 5000, 90014
Sponsors and Collaborators
University of Oulu
  More Information

Responsible Party: Heidi Jurvelin, Research coordinator, University of Oulu
ClinicalTrials.gov Identifier: NCT01784705     History of Changes
Other Study ID Numbers: VCT-003
Study First Received: February 4, 2013
Last Updated: June 27, 2013

Additional relevant MeSH terms:
Disease
Mood Disorders
Seasonal Affective Disorder
Pathologic Processes
Mental Disorders
Depressive Disorder

ClinicalTrials.gov processed this record on March 22, 2017