search
Back to results

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

Primary Purpose

Seasonal Affective Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
goLITE
Control
Sponsored by
Philips Respironics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seasonal Affective Disorder focused on measuring SAD, Seasonal Affective Disorder, Winter Blues, Seasonal Depression

Eligibility Criteria

21 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • McLean Hospital
  • Brigham & Women's Hospital
  • University of Minnesota
  • Community Research Management Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

goLITE

Control

Arm Description

light therapy using 467nm LED source, within 30 minutes of waking in the morning every day for 6 weeks

light therapy using 580nm LED source within 30 minutes of waking in the morning every day for 6 weeks

Outcomes

Primary Outcome Measures

SIGH-ADS Score
A Structured Interview Guide for the Hamilton Depression Scale with Atypical Depression Supplement was utilized at baseline and after 6 weeks of treatment. The SIGH-ADS is designed for general use in depression research and clinical evaluation, regardless of seasonality.The SIGH-ADS rates the severity of depressive symptoms in terms of Hamilton's 17-item depression score and an 8-item atypical score. Combined this provides 25 items to provide the SIGH-ADS score. SIGH-ADS scores range from 0-79; higher values represent increased depression severity and worse outcome, the lower the score the less depressed the patient is. All participants that entered the study had to have a score of 20 or greater.

Secondary Outcome Measures

SIGH-ADS Score (Week 1 Thru 5)
A Structured Interview Guide for the Hamilton Depression Scale with Atypical Depression Supplement was utilized weekly at in person visits or over the phone. The SIGH-ADS is designed for general use in depression research and clinical evaluation, regardless of seasonality.The SIGH-ADS rates the severity of depressive symptoms in terms of Hamilton's 17-item depression score and an 8-item atypical score. Combined this provides 25 items to provide the SIGH-ADS score. SIGH-ADS scores range from 0-79; higher values represent increased depression severity and worse outcome and the lower the score the less depressed the patient is. All participants that entered the study had to have a score of 20 or greater.
Q-LES-Q-SF
The Q-LES-Q-SF (Quality of life enjoyment and satisfaction questionnaire short form) is a 16 question questionnaire that is enables investigators to easily obtain sensitive measures of the degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning. Responses to questions range from 1 to 5, 1 being very poor and 5 being very good. Scores range from 16 to 80, the higher score the higher the participants enjoyment and satisfaction.

Full Information

First Posted
October 27, 2011
Last Updated
January 8, 2019
Sponsor
Philips Respironics
search

1. Study Identification

Unique Protocol Identification Number
NCT01462305
Brief Title
30-Minute Light Exposure for the Treatment of Seasonal Affective Disorder
Acronym
SAD
Official Title
30-Minute Light Exposure for the Treatment of Seasonal Affective Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
January 6, 2012 (Actual)
Primary Completion Date
April 2, 2012 (Actual)
Study Completion Date
April 2, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philips Respironics

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Affective Disorder
Keywords
SAD, Seasonal Affective Disorder, Winter Blues, Seasonal Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
goLITE
Arm Type
Experimental
Arm Description
light therapy using 467nm LED source, within 30 minutes of waking in the morning every day for 6 weeks
Arm Title
Control
Arm Type
Active Comparator
Arm Description
light therapy using 580nm LED source within 30 minutes of waking in the morning every day for 6 weeks
Intervention Type
Device
Intervention Name(s)
goLITE
Other Intervention Name(s)
Light device, Blue Light
Intervention Description
goLITE at 30 minutes per day, within 30 minutes of waking in the morning
Intervention Type
Device
Intervention Name(s)
Control
Intervention Description
light therapy using 580nm LED source within 30 minutes of waking in the morning every day for 6 weeks
Primary Outcome Measure Information:
Title
SIGH-ADS Score
Description
A Structured Interview Guide for the Hamilton Depression Scale with Atypical Depression Supplement was utilized at baseline and after 6 weeks of treatment. The SIGH-ADS is designed for general use in depression research and clinical evaluation, regardless of seasonality.The SIGH-ADS rates the severity of depressive symptoms in terms of Hamilton's 17-item depression score and an 8-item atypical score. Combined this provides 25 items to provide the SIGH-ADS score. SIGH-ADS scores range from 0-79; higher values represent increased depression severity and worse outcome, the lower the score the less depressed the patient is. All participants that entered the study had to have a score of 20 or greater.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
SIGH-ADS Score (Week 1 Thru 5)
Description
A Structured Interview Guide for the Hamilton Depression Scale with Atypical Depression Supplement was utilized weekly at in person visits or over the phone. The SIGH-ADS is designed for general use in depression research and clinical evaluation, regardless of seasonality.The SIGH-ADS rates the severity of depressive symptoms in terms of Hamilton's 17-item depression score and an 8-item atypical score. Combined this provides 25 items to provide the SIGH-ADS score. SIGH-ADS scores range from 0-79; higher values represent increased depression severity and worse outcome and the lower the score the less depressed the patient is. All participants that entered the study had to have a score of 20 or greater.
Time Frame
weekly, from Week 1 through week 5
Title
Q-LES-Q-SF
Description
The Q-LES-Q-SF (Quality of life enjoyment and satisfaction questionnaire short form) is a 16 question questionnaire that is enables investigators to easily obtain sensitive measures of the degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning. Responses to questions range from 1 to 5, 1 being very poor and 5 being very good. Scores range from 16 to 80, the higher score the higher the participants enjoyment and satisfaction.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males and females, ages 21-64 Able and willing to provide written informed consent 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 SIGH-ADS score of ≥20 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: 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 Subjects who are medically complicated, medically unstable and/or have other severe diseases, as determined by the investigator. Abnormal TSH level, (outside range of 0.3 to 5.0 mlU/L), as determined by the TSH levels blood test History of concurrent psychiatric illness that would preclude compliance with the protocol and/or ability to complete the study safely History or current diagnosis of Bipolar I Disorder Variable psychiatric symptoms such as rapid cycling or severe premenstrual syndrome that could interfere with accurate assessment of the treatment effect History of a medical condition that affects mood or produces hallmark symptoms of a mood disorder (i.e. hypothyroidism) History of current or recent (within previous 12 months) alcohol, narcotic or other drug abuse by DSM-IV criteria Positive urine drug screen at the Physical Screening Active suicidal or homicidal ideation or plan, as determined by the investigator Global Assessment of Functioning (GAF) <51 (see Appendix B) Use of light therapy treatment within the previous 6 months or any history of goLITE use 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 Current use or use within 2 months of antidepressants or mood stabilizing medications, even if taken for a non-psychiatric indication Currently working night shift or rotating shift or other habitual alteration of the sleep/wake cycle Planned travel outside of the state in which the trial is being conducted 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) 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 Ishihara score of <10 on the Ishihara Test for Color Deficiency 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janis Anderson, PhD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Auger, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Scott Crow, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carol Glod, PhD
Organizational Affiliation
Mclean Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alfredo Rivera, MD
Organizational Affiliation
Community Research Management Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
McLean Hospital
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Community Research Management Associates
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs