Bright Light Therapy in Seasonal Affective Disorder (SAD)

Seasonal Affective Disorder Clinical Trial

Official title:

Transcranial Brain-Targeted Bright Light Treatment Via Ear Canals in Seasonal Affective Disorder (SAD) - a Randomized Placebo Controlled Dose Finding Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01293409
• Other study ID #: FI (FWA00000190) 11/2008b
• Status: Completed
• Phase: N/A
• First received: January 21, 2011
• Last updated: May 30, 2011
• Start date: November 2010
• Est. completion date: March 2011

Study information

• Verified date: May 2011
• Source: University of Oulu
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: National Supervisory Authority for Welfare and Health (Valvira)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mood Disorders
• Seasonal Affective Disorder

Intervention

Other:
• Transcranial Brain-Targeted Bright Light Treatment
Transcranial Brain-Targeted Bright Light Treatment via Ear Canals

Locations

Country	Name	City	State
Finland	ODL Terveys Oy	Oulu

Sponsors (5)

Lead Sponsor	Collaborator
University of Oulu	ODL Terveys Oy, Oulu University Hospital, University of Eastern Finland, Valkee Oy

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The 29-item Structured Interview Guide for Hamilton Depression Rating Scale - Seasonal Affective Disorder Version (SIGH-SAD) total score = 8	Remission, i.e., the 29-item Structured Interview Guide for Hamilton Depression Rating Scale - Seasonal Affective Disorder Version (SIGH-SAD) total score = 8	At the end of the four-week study period	No
Secondary	= 50 % decrease of the severity of symptoms as assessed by SIGH-SAD		At the end of the four-week study period	No
Secondary	= 50 % decrease of the severity of symptoms as assessed by the 14-item Hamilton Anxiety Rating Scale total score		At the end of the four-week study period	No
Secondary	= 50 % decrease of the severity of symptoms as assessed by the 21-item Beck depression Inventory (BDI-21) total score		At the end of the four-week study period	No
Secondary	= 50 % decrease of the severity of symptoms as assessed by 21-item Hamilton Depression Rating Scale total score		At the end of the four-week study period	No
Secondary	A number of participants with bright light therapy related (according to physician decision) adverse events as a measure of safety and tolerability		During the four week study period	Yes