Seasonal Affective Disorder
Conditions
Brief summary
The aim of this study is to investigate the efficacy of bright light therapy in SAD. This is a placebo-controlled, double-blind randomized controlled trial (RCT).
Interventions
OTHERBright light therapy
Bright light therapy
OTHERInactive placebo-light
In this arm, patients will not get any bright-light therapy in a double-blind setting
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
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* a patient has, according to the DSM-IV-TR, a Major depression, recurrent episode, seasonal pattern, moderate or severe (classification code 296.32 and 296.33) * HAMD-21 (included in the SIGH-SAD) sum score is ≥ 22 * 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 * life-time suicide attempt, or any thought of suicide during the last month * patients has some unstable somatic disorder * patient uses some medication on regular basis * patient uses some herbal 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 during the current episode * patient has some eye disease (patient can, however, be myopic or hyperopic)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Remission as defined by the SIGH-SAD | 28 (visit window from 26 to 30 days) days after the inclusion day |
Secondary
| Measure | Time frame |
|---|---|
| Decrease of the severity of symptoms as assessed by SIGH-SAD, Hamilton anxiety scale, and Beck depression inventory-21 | 28 (visit window from 26 to 30 days) days |
Countries
Finland
Contacts
Primary ContactMarkku J Timonen, Prof
Outcome results
None listed