Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 3 for:    valkee

Bright Light Therapy in Seasonal Affective Disorder (SAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01293409
Recruitment Status : Completed
First Posted : February 10, 2011
Last Update Posted : June 1, 2011
Sponsor:
Collaborators:
Oulu University Hospital
ODL Terveys Oy
Valkee Oy
University of Eastern Finland
Information provided by:
University of Oulu

Tracking Information
First Submitted Date  ICMJE January 21, 2011
First Posted Date  ICMJE February 10, 2011
Last Update Posted Date June 1, 2011
Study Start Date  ICMJE November 2010
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2011)
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 ]
Remission, i.e., the 29-item Structured Interview Guide for Hamilton Depression Rating Scale - Seasonal Affective Disorder Version (SIGH-SAD) total score ≤ 8
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2011)
  • ≥ 50 % decrease of the severity of symptoms as assessed by SIGH-SAD [ Time Frame: At the end of the four-week study period ]
  • ≥ 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 ]
  • ≥ 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 ]
  • ≥ 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bright Light Therapy in Seasonal Affective Disorder (SAD)
Official Title  ICMJE Transcranial Brain-Targeted Bright Light Treatment Via Ear Canals in Seasonal Affective Disorder (SAD) - a Randomized Placebo Controlled Dose Finding Study
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Seasonal Affective Disorder
Intervention  ICMJE Other: Transcranial Brain-Targeted Bright Light Treatment
Transcranial Brain-Targeted Bright Light Treatment via Ear Canals
Other Name: VALKEE
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    The amount of photic energy of light is considered to be non-therapeutical
    Intervention: Other: Transcranial Brain-Targeted Bright Light Treatment
  • Experimental: Intermediate dose
    The amount of photic energy of bright light is considered to be "intermediate"
    Intervention: Other: Transcranial Brain-Targeted Bright Light Treatment
  • Experimental: High dose bright light
    The amount of photic energy of bright light is considered to be fully therapeutic
    Intervention: Other: Transcranial Brain-Targeted Bright Light Treatment
Publications * Jurvelin H, Takala T, Nissilä J, Timonen M, Rüger M, Jokelainen J, Räsänen P. Transcranial bright light treatment via the ear canals in seasonal affective disorder: a randomized, double-blind dose-response study. BMC Psychiatry. 2014 Oct 21;14:288. doi: 10.1186/s12888-014-0288-6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: February 9, 2011)
90
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01293409
Other Study ID Numbers  ICMJE FI (FWA00000190) 11/2008b
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not 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
Study Sponsor  ICMJE University of Oulu
Collaborators  ICMJE
  • Oulu University Hospital
  • ODL Terveys Oy
  • Valkee Oy
  • University of Eastern Finland
Investigators  ICMJE
Principal Investigator: Pirkko Räsänen, M.D., Ph.D. Professor
PRS Account University of Oulu
Verification Date May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP