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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Seasonal Affective Disorder	Other: Transcranial Brain-Targeted Bright Light Treatment	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, 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
• Study Start Date: November 2010
• Actual Primary Completion Date: March 2011
• Actual Study Completion Date: March 2011

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. ≥ 50 % decrease of the severity of symptoms as assessed by SIGH-SAD [ Time Frame: At the end of the four-week study period ]
2. ≥ 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 ]
3. ≥ 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 ]
4. ≥ 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 ]
5. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• 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
• Other Study ID Numbers: FI (FWA00000190) 11/2008b
• First Posted: February 10, 2011
• Last Update Posted: June 1, 2011
• Last Verified: May 2011

Additional relevant MeSH terms:

Mood Disorders; Seasonal Affective Disorder; Mental Disorders; Depressive Disorder