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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2009 by University of Oulu.
Recruitment status was:  Recruiting
Oulu University Hospital
ODL Terveys Oy
Valkee Oy
University of Eastern Finland
Information provided by:
University of Oulu Identifier:
First received: December 10, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
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).

Condition Intervention
Seasonal Affective Disorder Other: Bright light therapy Other: Inactive "placebo-light"

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Placebo-controlled, Double Blind RCT on the Efficacy of Bright Light Therapy in SAD

Resource links provided by NLM:

Further study details as provided by University of Oulu:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: October 2009
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01030276

Contact: Markku J Timonen, Prof +358 40 8324883

Research unit, ODL Terveys Oy, Albertinkatu 18 A Recruiting
Oulu, Finland, FIN-90100 Oulu
Contact: Markku J Timonen, Prof    + 358 40 8324883   
Sponsors and Collaborators
University of Oulu
Oulu University Hospital
ODL Terveys Oy
Valkee Oy
University of Eastern Finland
  More Information

Responsible Party: Osmo Tervonen, professor of Radiology, Institute of Diagnostics (Radiology), University of Oulu, Box 5000, FIN-90014 University of Oulu, Finland Identifier: NCT01030276     History of Changes
Other Study ID Numbers: FI (FWA00000190) 11/2008
Study First Received: December 10, 2009
Last Updated: December 10, 2009

Additional relevant MeSH terms:
Mood Disorders
Seasonal Affective Disorder
Mental Disorders
Depressive Disorder processed this record on September 20, 2017