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

NCT01462305 | Completed Results

• 1 other identifier: CL-1033-SADGO-MS
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 4

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.

Conditions

Seasonal Affective Disorder

Keywords

SAD; Seasonal Affective Disorder; Winter Blues; Seasonal Depression

Outcome Measures

Primary Outcomes (1)

• 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.

  6 weeks

Secondary Outcomes (2)

• SIGH-ADS Score (Week 1 Thru 5)

  weekly, from Week 1 through week 5

• Q-LES-Q-SF

  6 weeks

Study Arms (2)

goLITE

EXPERIMENTAL

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

Device: goLITE

Control

ACTIVE COMPARATOR

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

Device: Control

Interventions

goLITE DEVICE

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

Also known as: Light device, Blue Light

goLITE

Control DEVICE

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

Control

Eligibility Criteria

• Age: 21 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Philips Respironics: lead

Study Sites (4)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Community Research Management Associates

Cincinnati, Ohio, 45227, United States

Location

MeSH Terms

Conditions

Seasonal Affective Disorder

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Sr. Clinical Development Scientisit
• Organization: Philips

fatima.sertkuniyoshi@philips.com

+41 79 460 0622

Study Officials

• Janis Anderson, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

• Robert Auger, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Scott Crow, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

• Carol Glod, PhD

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

• Alfredo Rivera, MD

  Community Research Management Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2011
• First Posted: October 31, 2011
• Study Start: January 6, 2012
• Primary Completion: April 2, 2012
• Study Completion: April 2, 2012
• Last Updated: January 30, 2019
• Results First Posted: January 30, 2019

Record last verified: 2019-01

Locations

US (4)