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

NCT ID: NCT01462305

Last Updated: 2019-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-06
• Study Completion Date: 2012-04-02

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.

Conditions

Seasonal Affective Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

goLITE

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

Group Type: EXPERIMENTAL

goLITE

Intervention Type: DEVICE

goLITE at 30 minutes per day, within 30 minutes of waking in the morning

Control

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

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: DEVICE

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

Interventions

goLITE

goLITE at 30 minutes per day, within 30 minutes of waking in the morning

Intervention Type: DEVICE

Control

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

Intervention Type: DEVICE

Other Intervention Names

Light device; Blue Light

Eligibility 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Philips Respironics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janis Anderson, PhD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Robert Auger, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Scott Crow, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Carol Glod, PhD

Role: PRINCIPAL_INVESTIGATOR

Mclean Hospital

Alfredo Rivera, MD

Role: PRINCIPAL_INVESTIGATOR

Community Research Management Associates

Locations

McLean Hospital

Belmont, Massachusetts, United States

Brigham & Women's Hospital

Boston, Massachusetts, United States

University of Minnesota

Minneapolis, Minnesota, United States

Community Research Management Associates

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

CL-1033-SADGO-MS

Identifier Type: -

Identifier Source: org_study_id