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| Name | Class |
|---|---|
| Oulu University Hospital | OTHER |
| ODL Terveys Oy | UNKNOWN |
| Valkee Oy | INDUSTRY |
| University of Eastern Finland |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | The amount of photic energy of light is considered to be non-therapeutical |
|
| Intermediate dose | Experimental | The amount of photic energy of bright light is considered to be "intermediate" |
|
| High dose bright light | Experimental | The amount of photic energy of bright light is considered to be fully therapeutic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Brain-Targeted Bright Light Treatment | Other | Transcranial Brain-Targeted Bright Light Treatment via Ear Canals |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| ≥ 50 % decrease of the severity of symptoms as assessed by SIGH-SAD | 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 | At the end of the four-week study period |
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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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pirkko Räsänen, M.D., Ph.D. | Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ODL Terveys Oy | Oulu | 90100 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25330838 | Derived | 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. |
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| ID | Term |
|---|---|
| D016574 | Seasonal Affective Disorder |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| OTHER |
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|
| ≥ 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 |
| ≥ 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 |
| 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 |