Bright Light Therapy in Seasonal Affective Disorder (SAD)

• ClinicalTrials.gov Identifier: NCT01293409
• Recruitment Status: Completed
• First Posted: February 10, 2011
• Last Update Posted: June 1, 2011
• Sponsor: University of Oulu
• Collaborators: Oulu University Hospital; ODL Terveys Oy; Valkee Oy; University of Eastern Finland
• Information provided by: University of Oulu

Tracking Information

• First Submitted Date: January 21, 2011
• First Posted Date: February 10, 2011
• Last Update Posted Date: June 1, 2011
• Study Start Date: November 2010
• Actual Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Bright Light Therapy in Seasonal Affective Disorder (SAD)
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Seasonal Affective Disorder

Intervention

Other: Transcranial Brain-Targeted Bright Light Treatment

Transcranial Brain-Targeted Bright Light Treatment via Ear Canals

Other Name: VALKEE

Study Arms

• 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, Nissila J, Timonen M, Ruger M, Jokelainen J, Rasanen 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.

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: February 9, 2011): 90
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: March 2011
• Actual Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Finland

Administrative Information

• NCT Number: NCT01293409
• Other Study ID Numbers: FI (FWA00000190) 11/2008b
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current 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
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Oulu
• Original Study Sponsor: Same as current

Collaborators

• Oulu University Hospital
• ODL Terveys Oy
• Valkee Oy
• University of Eastern Finland

Investigators

• Principal Investigator: Pirkko Räsänen, M.D., Ph.D.; Professor

• PRS Account: University of Oulu
• Verification Date: May 2011