Clinical trial NCT01293409: 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
Overall status: COMPLETED
Phase: NA
Conditions: Seasonal Affective Disorder
Lead sponsor: University of Oulu
Sponsor class: OTHER
Collaborators: name: Oulu University Hospital
name: ODL Terveys Oy
name: Valkee Oy
name: University of Eastern Finland
First posted: 2011-02-10
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: The 29-item Structured Interview Guide for Hamilton Depression Rating Scale - Seasonal Affective Disorder Version (SIGH-SAD) total score ≤ 8
timeFrame: At the end of the four-week study period
Secondary outcomes:
measure: ≥ 50 % decrease of the severity of symptoms as assessed by SIGH-SAD
timeFrame: At the end of the four-week study period
measure: ≥ 50 % decrease of the severity of symptoms as assessed by the 14-item Hamilton Anxiety Rating Scale total score
timeFrame: At the end of the four-week study period
measure: ≥ 50 % decrease of the severity of symptoms as assessed by the 21-item Beck depression Inventory (BDI-21) total score
timeFrame: At the end of the four-week study period
measure: ≥ 50 % decrease of the severity of symptoms as assessed by 21-item Hamilton Depression Rating Scale total score
timeFrame: At the end of the four-week study period
measure: A number of participants with bright light therapy related (according to physician decision) adverse events as a measure of safety and tolerability
timeFrame: During the four week study period
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: ODL Terveys Oy
Study officials:
affiliation: Professor
name: Pirkko Räsänen, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.