Environmental Treatment for Seasonal Affective Disorder (SAD)

This study has been completed.
Sponsor:
Collaborators:
University Medical Centre Groningen
University of British Columbia
Royal Ottawa Mental Health Centre
Douglas Hospital Research Centre
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00139997
First received: August 29, 2005
Last updated: January 29, 2013
Last verified: January 2013
  Purpose

The purpose is to study treatments of Seasonal Affective Disorder (SAD).


Condition Intervention
Seasonal Affective Disorder
Device: Litebook treatment devices
Device: Inactivated negative ion generator

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized Controlled Trial of Negative Ion Generation Versus Light-Emitting Diode Phototherapy For Seasonal Affective Disorder

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Percentage SIGH SAD (Structured Interview Guide For The Hamilton Depression Rating Scale), SAD Version [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

    SIGH SAD Structured Interview Guide for the Hamilton Depression Rating Scale, Seasonal Affective Disorder (SAD)version. The items are augmented with additional items to reflect better the atypical depressive symptoms usually seen in SAD, eg, increased sleep, weight, appetite and fatigue. On this scale, higher scores reflect increased depression intensity. The maximum score attainable is 63, and the minimum is 0. A score of less than 9 is regarded as consistent with normal mood, the absence of major depression.

    Calculated: SIGH SAD score at trial end x 100 / SIGH SAD score at randomization



Secondary Outcome Measures:
  • SIGH SAD (Structured Interview Guide For The Hamilton Depression Rating Scale), SAD Version [ Time Frame: Weekly following randomization ] [ Designated as safety issue: No ]
    SIGH SAD Structured Interview Guide for the Hamilton Depression Rating Scale, SIGH SAD Structured Interview Guide for the Hamilton Depression Rating Scale, Seasonal Affective Disorder (SAD)version. This is a structured interview, which is an interview in which the clinician is provided exact questions to use to inquire about symptoms of depression and explicit standards for rating the intensity of each symptom item. The interview assesses the symptoms which make up the Hamilton Depression Rating Scale, which is the standard in the majority of clinical trials in depression. The items are augmented with additional items to reflect better the atypical depressive symptoms usually seen in SAD, eg, increased sleep, weight, appetite and fatigue. On this scale, higher scores reflect increased depression intensity. The maximum score attainable is 63, and the minimum is 0. A score of less than 9 is regarded as consistent with normal mood, the absence of major depression.


Enrollment: 26
Study Start Date: January 2002
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LED phototherapy device
Litebook treatment devices: LED phototherapy device, used for 30 min before 8 am
Device: Litebook treatment devices
Litebook LED phototherapy device used for 30 min before 8 am
Placebo Comparator: Inactivated Negative Ion Generator
Equivalent exposure to inactivated negative ion generator
Device: Inactivated negative ion generator
Equivalent exposure to inactivated negative ion generator

Detailed Description:

This is a multicenter, randomized controlled trial of negative ion generation versus light-emitting diode phototherapy for seasonal affective disorder. Participants appropriate for the study are subjects with a DSM IV diagnosis of Major Depression, with seasonal pattern, winter type. Subjects were seen at Yale University,New Haven,CT University of British Columbia,Vancouver,BC Groningen University Hospital,Groningen, The Netherlands, Royal Ottawa Hospital, Ottawa,Ontario, McGill University, Montreal,Quebec, University Hospital,Saskatoon, Saskatchewan. The trial is 4 weeks in duration.

This trial has now been completed.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects meet DSM-IV criteria for major depressive episodes with a seasonal pattern, winter type.

Exclusion Criteria:

  • Significant suicidal risk
  • Serious medical illness
  • Pregnancy
  • Other DSM-IV diagnoses
  • Taking mood altering medication
  • May not travel to a sunny destination during study
  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: NCT00139997

Locations
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06504
Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada, V6T 2A1
Canada, Ontario
Royal Ottawa Mental Health Centre, , Ontario, K1Z 7K4 Canada
Ottawa, Ontario, Canada, K1Z 7K4
Canada, Quebec
Douglas Hospital Research Centre
Montreal, Quebec, Canada, H4H 1R3
Netherlands
University Medical Center Groningen
Groningen, RB, Netherlands, 9700
Sponsors and Collaborators
Yale University
University Medical Centre Groningen
University of British Columbia
Royal Ottawa Mental Health Centre
Douglas Hospital Research Centre
Investigators
Principal Investigator: Paul H. Desan, PhD, MD Yale New Haven Health System Center for Healthcare Solutions
  More Information

Publications:
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00139997     History of Changes
Other Study ID Numbers: 22,777, 22,777
Study First Received: August 29, 2005
Results First Received: September 7, 2012
Last Updated: January 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Major Depression
Seasonal Affective Disorder (SAD)

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

ClinicalTrials.gov processed this record on August 01, 2014