Back to resultsBright Light Therapy in Seasonal Affective Disorder (SAD)
Primary Purpose
Seasonal Affective Disorder
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Transcranial Brain-Targeted Bright Light Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Seasonal Affective Disorder
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
Sites / Locations
- ODL Terveys Oy
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo
Intermediate dose
High dose bright light
Arm Description
The amount of photic energy of light is considered to be non-therapeutical
The amount of photic energy of bright light is considered to be "intermediate"
The amount of photic energy of bright light is considered to be fully therapeutic
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
≥ 50 % decrease of the severity of symptoms as assessed by SIGH-SAD
≥ 50 % decrease of the severity of symptoms as assessed by the 14-item Hamilton Anxiety Rating Scale total score
≥ 50 % decrease of the severity of symptoms as assessed by the 21-item Beck depression Inventory (BDI-21) total score
≥ 50 % decrease of the severity of symptoms as assessed by 21-item Hamilton Depression Rating Scale total score
A number of participants with bright light therapy related (according to physician decision) adverse events as a measure of safety and tolerability
Full Information
NCT ID
NCT01293409
First Posted
January 21, 2011
Last Updated
May 30, 2011
Sponsor
University of Oulu
Collaborators
Oulu University Hospital, ODL Terveys Oy, Valkee Oy, University of Eastern Finland
1. Study Identification
Unique Protocol Identification Number
NCT01293409
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Oulu
Collaborators
Oulu University Hospital, ODL Terveys Oy, Valkee Oy, University of Eastern Finland
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Affective Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The amount of photic energy of light is considered to be non-therapeutical
Arm Title
Intermediate dose
Arm Type
Experimental
Arm Description
The amount of photic energy of bright light is considered to be "intermediate"
Arm Title
High dose bright light
Arm Type
Experimental
Arm Description
The amount of photic energy of bright light is considered to be fully therapeutic
Intervention Type
Other
Intervention Name(s)
Transcranial Brain-Targeted Bright Light Treatment
Other Intervention Name(s)
VALKEE
Intervention Description
Transcranial Brain-Targeted Bright Light Treatment via Ear Canals
Primary Outcome Measure Information:
Title
The 29-item Structured Interview Guide for Hamilton Depression Rating Scale - Seasonal Affective Disorder Version (SIGH-SAD) total score ≤ 8
Description
Remission, i.e., 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
Secondary Outcome Measure Information:
Title
≥ 50 % decrease of the severity of symptoms as assessed by SIGH-SAD
Time Frame
At the end of the four-week study period
Title
≥ 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
Title
≥ 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
Title
≥ 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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pirkko Räsänen, M.D., Ph.D.
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
ODL Terveys Oy
City
Oulu
ZIP/Postal Code
90100
Country
Finland
12. IPD Sharing Statement
Citations:
PubMed Identifier
25330838
Citation
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.
Results Reference
derived
Learn more about this trial
Bright Light Therapy in Seasonal Affective Disorder (SAD)
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