Bright Light Therapy in Seasonal Affective Disorder (SAD)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01030276
• Date of registration: 10/12/2009
• Prospective Registration: No
• Primary sponsor: University of Oulu
• Public title: Bright Light Therapy in Seasonal Affective Disorder (SAD) VAHAVA
• Scientific title: Placebo-controlled, Double Blind RCT on the Efficacy of Bright Light Therapy in SAD
• Date of first enrolment: October 2009
• Target sample size: 60
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01030276
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Finland

Contacts

• Name: Markku J Timonen, Prof

• Name: Markku J Timonen, Prof

Key inclusion & exclusion criteria

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)



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Seasonal Affective Disorder

Intervention(s)

Other: Bright light therapy

Other: Inactive "placebo-light"

Primary Outcome(s)

Remission as defined by the SIGH-SAD [Time Frame: 28 (visit window from 26 to 30 days) days after the inclusion day]

Secondary Outcome(s)

Decrease of the severity of symptoms as assessed by SIGH-SAD, Hamilton anxiety scale, and Beck depression inventory-21 [Time Frame: 28 (visit window from 26 to 30 days) days]

Secondary ID(s)

FI (FWA00000190) 11/2008

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

ODL Terveys Oy

Oulu University Hospital

Valkee Oy

University of Eastern Finland