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

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ClinicalTrials.gov Identifier: NCT01030276
Recruitment Status : Unknown
Verified December 2009 by University of Oulu.
Recruitment status was:  Recruiting
First Posted : December 11, 2009
Last Update Posted : December 11, 2009
Sponsor:
Collaborators:
Oulu University Hospital
ODL Terveys Oy
Valkee Oy
University of Eastern Finland
Information provided by:
University of Oulu

Study Description
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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).

Condition or disease Intervention/treatment Phase
Seasonal Affective Disorder Other: Bright light therapy Other: Inactive "placebo-light" Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Study Start Date : October 2009
Estimated Primary Completion Date : March 2011
Estimated Study Completion Date : April 2011

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01030276


Contacts
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Contact: Markku J Timonen, Prof +358 40 8324883 markku.timonen@oulu.fi

Locations
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Finland
Research unit, ODL Terveys Oy, Albertinkatu 18 A Recruiting
Oulu, Finland, FIN-90100 Oulu
Contact: Markku J Timonen, Prof    + 358 40 8324883    markku.timonen@oulu.fi   
Sponsors and Collaborators
University of Oulu
Oulu University Hospital
ODL Terveys Oy
Valkee Oy
University of Eastern Finland
More Information
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Responsible Party: Osmo Tervonen, professor of Radiology, Institute of Diagnostics (Radiology), University of Oulu, Box 5000, FIN-90014 University of Oulu, Finland
ClinicalTrials.gov Identifier: NCT01030276    
Other Study ID Numbers: FI (FWA00000190) 11/2008
First Posted: December 11, 2009    Key Record Dates
Last Update Posted: December 11, 2009
Last Verified: December 2009
Additional relevant MeSH terms:
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Mood Disorders
Seasonal Affective Disorder
Mental Disorders
Depressive Disorder