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Trial record 3 of 3 for:    valkee

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE December 10, 2009
First Posted Date  ICMJE December 11, 2009
Last Update Posted Date December 11, 2009
Study Start Date  ICMJE October 2009
Estimated Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2009)
Remission as defined by the SIGH-SAD [ Time Frame: 28 (visit window from 26 to 30 days) days after the inclusion day ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2009)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bright Light Therapy in Seasonal Affective Disorder (SAD)
Official Title  ICMJE Placebo-controlled, Double Blind RCT on the Efficacy of Bright Light Therapy in SAD
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Seasonal Affective Disorder
Intervention  ICMJE
  • Other: Bright light therapy
    Bright light therapy
  • Other: Inactive "placebo-light"
    In this arm, patients will not get any bright-light therapy in a double-blind setting
Study Arms  ICMJE
  • Experimental: Bright light
    Intervention: Other: Bright light therapy
  • Placebo Comparator: Inactive "placebo-light"
    Intervention: Other: Inactive "placebo-light"
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 10, 2009)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2011
Estimated Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01030276
Other Study ID Numbers  ICMJE FI (FWA00000190) 11/2008
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Osmo Tervonen, professor of Radiology, Institute of Diagnostics (Radiology), University of Oulu, Box 5000, FIN-90014 University of Oulu, Finland
Study Sponsor  ICMJE University of Oulu
Collaborators  ICMJE
  • Oulu University Hospital
  • ODL Terveys Oy
  • Valkee Oy
  • University of Eastern Finland
Investigators  ICMJE Not Provided
PRS Account University of Oulu
Verification Date December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP