Seasonal Affective Disorder
Conditions
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.
Interventions
OTHERTranscranial Brain-Targeted Bright Light Treatment
Transcranial Brain-Targeted Bright Light Treatment via Ear Canals
Sponsors
Oulu University Hospital
ODL Terveys Oy
Valkee Oy
University of Eastern Finland
University of Oulu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Remission, i.e., the 29-item Structured Interview Guide for Hamilton Depression Rating Scale - Seasonal Affective Disorder Version (SIGH-SAD) total score ≤ 8 |
Secondary
| Measure | Time frame |
|---|---|
| ≥ 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 |
| ≥ 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 |
| ≥ 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 |
Countries
Finland
Outcome results
None listed