Bright Light Therapy in Seasonal Affective Disorder (SAD)

Seasonal Affective Disorder Clinical Trial

— VAHAVA  

Official title:

Placebo-controlled, Double Blind RCT on the Efficacy of Bright Light Therapy in SAD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01030276
• Other study ID #: FI (FWA00000190) 11/2008
• Status: Recruiting
• Phase: N/A
• First received: December 10, 2009
• Last updated: December 10, 2009
• Start date: October 2009
• Est. completion date: April 2011

Study information

• Verified date: December 2009
• Source: University of Oulu
• Contact: Markku J Timonen, Prof
• Phone: +358 40 8324883
• Email: markku.timonen[@]oulu.fi
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mood Disorders
• Seasonal Affective Disorder

Intervention

Other:
• Bright light therapy
Bright light therapy
• Inactive "placebo-light"
In this arm, patients will not get any bright-light therapy in a double-blind setting

Locations

Country	Name	City	State
Finland	Research unit, ODL Terveys Oy, Albertinkatu 18 A	Oulu

Sponsors (5)

Lead Sponsor	Collaborator
University of Oulu	ODL Terveys Oy, Oulu University Hospital, University of Eastern Finland, Valkee Oy

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remission as defined by the SIGH-SAD		28 (visit window from 26 to 30 days) days after the inclusion day	No
Secondary	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	No