Bright Light Therapy in Seasonal Affective Disorder (SAD)

Not Applicable

• Conditions: Seasonal Affective Disorder
• Interventions: Other: Bright light therapy; Other: Inactive "placebo-light"

• Registration Number: NCT01030276
• Lead Sponsor: University of Oulu

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Status Verified: 2009-12
• Study First Submitted: 2009-12-10
• Study First Submitted QC: 2009-12-10
• Last Update Submitted: 2009-12-10
• Study First Posted: 2009-12-11
• Last Update Posted: 2009-12-11
• Primary Completion: 2011-03
• Study Completion: 2011-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bright light	Bright light therapy	-
Inactive "placebo-light"	Inactive "placebo-light"	-

Primary Outcome Measures

Name	Time	Method
Remission as defined by the SIGH-SAD	28 (visit window from 26 to 30 days) days after the inclusion day

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research unit, ODL Terveys Oy, Albertinkatu 18 A; 🇫🇮 Oulu, Finland