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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by University of Oulu.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Oulu University Hospital
ODL Terveys Oy
Valkee Oy
University of Eastern Finland
Information provided by:
University of Oulu
ClinicalTrials.gov Identifier:
NCT01030276
First received: December 10, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT01030276

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

Locations
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

No publications provided

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     History of Changes
Other Study ID Numbers: FI (FWA00000190) 11/2008
Study First Received: December 10, 2009
Last Updated: December 10, 2009
Health Authority: Finland: Ethics Committee

Additional relevant MeSH terms:
Disease
Mood Disorders
Seasonal Affective Disorder
Pathologic Processes
Mental Disorders
Depressive Disorder

ClinicalTrials.gov processed this record on September 29, 2014