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Bright Light Therapy in Seasonal Affective Disorder (SAD)

This study has been completed.
Sponsor:
Collaborators:
Oulu University Hospital
ODL Terveys Oy
Valkee Oy
University of Eastern Finland
Information provided by:
University of Oulu
ClinicalTrials.gov Identifier:
NCT01293409
First received: January 21, 2011
Last updated: May 30, 2011
Last verified: May 2011
History of Changes
  Purpose

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.


Condition Intervention
Seasonal Affective Disorder
 Other: Transcranial Brain-Targeted Bright Light Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcranial Brain-Targeted Bright Light Treatment Via Ear Canals in Seasonal Affective Disorder (SAD) - a Randomized Placebo Controlled Dose Finding Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Oulu:

Primary Outcome Measures:
  • The 29-item Structured Interview Guide for Hamilton Depression Rating Scale - Seasonal Affective Disorder Version (SIGH-SAD) total score ≤ 8 [ Time Frame: At the end of the four-week study period ] [ Designated as safety issue: No ]
    Remission, i.e., the 29-item Structured Interview Guide for Hamilton Depression Rating Scale - Seasonal Affective Disorder Version (SIGH-SAD) total score ≤ 8


Secondary Outcome Measures:
  • ≥ 50 % decrease of the severity of symptoms as assessed by SIGH-SAD [ Time Frame: At the end of the four-week study period ] [ Designated as safety issue: No ]
  • ≥ 50 % decrease of the severity of symptoms as assessed by the 14-item Hamilton Anxiety Rating Scale total score [ Time Frame: At the end of the four-week study period ] [ Designated as safety issue: No ]
  • ≥ 50 % decrease of the severity of symptoms as assessed by the 21-item Beck depression Inventory (BDI-21) total score [ Time Frame: At the end of the four-week study period ] [ Designated as safety issue: No ]
  • ≥ 50 % decrease of the severity of symptoms as assessed by 21-item Hamilton Depression Rating Scale total score [ Time Frame: At the end of the four-week study period ] [ Designated as safety issue: No ]
  • A number of participants with bright light therapy related (according to physician decision) adverse events as a measure of safety and tolerability [ Time Frame: During the four week study period ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 90
Study Start Date: November 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
The amount of photic energy of light is considered to be non-therapeutical
 Other: Transcranial Brain-Targeted Bright Light Treatment
Transcranial Brain-Targeted Bright Light Treatment via Ear Canals
Other Name: VALKEE
Experimental: Intermediate dose
The amount of photic energy of bright light is considered to be "intermediate"
 Other: Transcranial Brain-Targeted Bright Light Treatment
Transcranial Brain-Targeted Bright Light Treatment via Ear Canals
Other Name: VALKEE
Experimental: High dose bright light
The amount of photic energy of bright light is considered to be fully therapeutic
 Other: Transcranial Brain-Targeted Bright Light Treatment
Transcranial Brain-Targeted Bright Light Treatment via Ear Canals
Other Name: VALKEE

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01293409

Locations
Finland
ODL Terveys Oy
Oulu, Finland, 90100
Sponsors and Collaborators
University of Oulu
Oulu University Hospital
ODL Terveys Oy
Valkee Oy
University of Eastern Finland
Investigators
Principal Investigator: Pirkko Räsänen, M.D., Ph.D. Professor
  More Information

No publications provided

Responsible Party: Professor Pirkko Räsänen, M.D., Ph.D., University of Oulu, Institute of Clinical Medicine, Department of Psychiatry, Box 5000, FIN-90014 University of Oulu, Finland
ClinicalTrials.gov Identifier: NCT01293409     History of Changes
Other Study ID Numbers: FI (FWA00000190) 11/2008b
Study First Received: January 21, 2011
Last Updated: May 30, 2011
Health Authority: Finland: National Supervisory Authority for Welfare and Health (Valvira)

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

ClinicalTrials.gov processed this record on May 22, 2013