30-Minute Light Exposure for the Treatment of Seasonal Affective Disorder (SAD)

This study has been terminated.
(enrollment targets having been met)
Sponsor:
Information provided by (Responsible Party):
Philips Respironics
ClinicalTrials.gov Identifier:
NCT01462305
First received: October 27, 2011
Last updated: August 6, 2012
Last verified: August 2012
  Purpose

The primary objective of this study is to evaluate the effect of light therapy using a narrow 467nm light compared to a 580nm light in subjects with Seasonal Affective Disorder (SAD). It is hypothesized that the 467nm light will improve the symptoms of SAD better than the 580nm light.


Condition Intervention
Seasonal Affective Disorder
Device: goLITE
Device: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 30-Minute Light Exposure for the Treatment of Seasonal Affective Disorder

Resource links provided by NLM:


Further study details as provided by Philips Respironics:

Primary Outcome Measures:
  • SIGH-ADS Score [ Time Frame: 6 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SIGH-ADS Score [ Time Frame: at 5, 4, 3, 2 and 1 week of treatment ] [ Designated as safety issue: No ]
  • Q-LES-Q-SF [ Time Frame: at week 3 and week 6 of treatment ] [ Designated as safety issue: No ]
    Quality of life enjoyment and satisfaction questionnaire short form


Enrollment: 36
Study Start Date: December 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: goLITE
light therapy using 467nm LED source, within 30 minutes of waking in the morning every day for 6 weeks
Device: goLITE
goLITE at 30 minutes per day, within 30 minutes of waking in the morning
Other Names:
  • Light device
  • Blue Light
Active Comparator: Control
light therapy using 580nm LED source within 30 minutes of waking in the morning every day for 6 weeks
Device: Control
light therapy using 580nm LED source within 30 minutes of waking in the morning every day for 6 weeks

Detailed Description:

Participants will be randomly assigned to receive either a 467nm light or a 580nm light. Participants will use the light every day for six weeks for 30 minutes. Multiple assessments and questionnaires will be given weekly to assess the efficacy of the treatment.

  Eligibility

Ages Eligible for Study:   21 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males and females, ages 21-64
  2. Able and willing to provide written informed consent
  3. History of recurrent major depressive episodes with winter-type seasonal pattern by Diagnostic and Statistical Manual of the American Psychiatric Associated, 4th Ed. (DSM-IV) criteria (American Psychiatric Association, 1990), based on diagnostic interview utilizing the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I) (First et al., 2007)

    *Bipolar I excluded for this study

  4. SIGH-ADS score of ≥20
  5. Use of the light device as instructed by the study clinician for at least 6 out of 7 days for the first two weeks of therapy and at least 5 out of 7 days for the remaining four weeks of therapy.

Exclusion Criteria:

  1. Participation in a study of investigational or marketed drugs or devices during the 30-day period prior to the start of the study or during the study
  2. Subjects who are medically complicated, medically unstable and/or have other severe diseases, as determined by the investigator.
  3. Abnormal TSH level, (outside range of 0.3 to 5.0 mlU/L), as determined by the TSH levels blood test
  4. History of concurrent psychiatric illness that would preclude compliance with the protocol and/or ability to complete the study safely
  5. History or current diagnosis of Bipolar I Disorder
  6. Variable psychiatric symptoms such as rapid cycling or severe premenstrual syndrome that could interfere with accurate assessment of the treatment effect
  7. History of a medical condition that affects mood or produces hallmark symptoms of a mood disorder (i.e. hypothyroidism)
  8. History of current or recent (within previous 12 months) alcohol, narcotic or other drug abuse by DSM-IV criteria
  9. Positive urine drug screen at the Physical Screening
  10. Active suicidal or homicidal ideation or plan, as determined by the investigator
  11. Global Assessment of Functioning (GAF) <51 (see Appendix B)
  12. Use of light therapy treatment within the previous 6 months or any history of goLITE use
  13. Pregnant or lactating (will confirm absence of pregnancy with a urine or serum pregnancy test in females of childbearing potential during the Physical Screening. Additional pregnancy tests may be performed as per individual site requirements). Females of child-bearing potential must agree to use some form of birth control throughout the course
  14. Current use or use within 2 months of antidepressants or mood stabilizing medications, even if taken for a non-psychiatric indication
  15. Currently working night shift or rotating shift or other habitual alteration of the sleep/wake cycle
  16. Planned travel outside of the state in which the trial is being conducted
  17. Current use or use within the previous 1 month of photosensitizing medications (amiodarone, benoxaprofen, chlorpromazine, demeclocycline, fleroxacin, nalidixic acid, ofloxacin, piroxicam, porfimer, psoralens, quinidine, temoporfin) or remedies (St. John's wort, melatonin)
  18. History of eye trauma or disease, retinopathy, and/or cataract of a level that would significantly affect transmission or processing of light through either eye
  19. Ishihara score of <10 on the Ishihara Test for Color Deficiency
  20. Use of medications, such as tetracycline or oral isoretinoin (Accutane), that would affect the safety of light exposure treatment or that causes complaints of eyestrain or abnormal tearing with computer use of up to 30 minutes at a time
  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: NCT01462305

Locations
United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Ohio
Community Research Management Associates
Cincinnati, Ohio, United States, 45227
Sponsors and Collaborators
Philips Respironics
Investigators
Principal Investigator: Janis Anderson, PhD Brigham and Women's Hospital
Principal Investigator: Robert Auger, MD Mayo Clinic
Principal Investigator: Scott Crow, MD University of Minnesota - Clinical and Translational Science Institute
Principal Investigator: Carol Glod, PhD Mclean Hospital
Principal Investigator: Alfredo Rivera, MD Community Research Management Associates
  More Information

Additional Information:
No publications provided

Responsible Party: Philips Respironics
ClinicalTrials.gov Identifier: NCT01462305     History of Changes
Other Study ID Numbers: CL-1033-SADGO-MS
Study First Received: October 27, 2011
Last Updated: August 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Philips Respironics:
SAD
Seasonal Affective Disorder
Winter Blues
Seasonal Depression

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

ClinicalTrials.gov processed this record on August 27, 2014