Bright Light Therapy in Seasonal Affective Disorder (SAD) (VAHAVA)

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

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).

Study Overview

• Status: Unknown
• Conditions: Seasonal Affective Disorder
• Intervention / Treatment: Other: Bright light therapy; Other: Inactive "placebo-light"

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Markku J Timonen, Prof; Phone Number: +358 40 8324883; Email: markku.timonen@oulu.fi

Study Locations

• Finland
  • Oulu, Finland, FIN-90100 Oulu
    • Recruiting
    • Research unit, ODL Terveys Oy, Albertinkatu 18 A
    • Contact: Markku J Timonen, Prof; Phone Number: + 358 40 8324883; Email: markku.timonen@oulu.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bright light	Other: Bright light therapy; Bright light therapy
Placebo Comparator: Inactive "placebo-light"	Other: Inactive "placebo-light"; In this arm, patients will not get any bright-light therapy in a double-blind setting

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: University of Oulu
• Collaborators: Oulu University Hospital; University of Eastern Finland; ODL Terveys Oy; Valkee Oy

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Anticipated): March 1, 2011
• Study Completion (Anticipated): April 1, 2011

Study Registration Dates

• First Submitted: December 10, 2009
• First Submitted That Met QC Criteria: December 10, 2009
• First Posted (Estimate): December 11, 2009

Study Record Updates

• Last Update Posted (Estimate): December 11, 2009
• Last Update Submitted That Met QC Criteria: December 10, 2009
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Depressive Disorder; Mood Disorders; Seasonal Affective Disorder
• Other Study ID Numbers: FI (FWA00000190) 11/2008