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Predicting Effectiveness of Light Treatment for Winter Seasonal Affective Disorder

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00742365
First Posted: August 27, 2008
Last Update Posted: April 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Maryland
  Purpose
This study will evaluate a possible tool for predicting future effectiveness of bright light in treating seasonal affective disorder, winter subtype, and will examine secondary effects of bright light on cardiovascular risk factors.

Condition Intervention
Depression Device: Bright light Device: Red light placebo

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predicting Light Treatment's Effectiveness on Reducing Depression and Cardiovascular Risk in Seasonal Affective Disorder

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Hamilton rating scale for depressional seasonal affective disorder (SIGH SAD) [ Time Frame: Measured at baseline, 1 hour after light treatment, and weekly for 6 weeks ]

Secondary Outcome Measures:
  • Hunger questionnaire [ Time Frame: Measured daily for 6 weeks ]
  • Three factor eating questionnaire [ Time Frame: Measured weekly for 6 weeks ]
  • Sleep log [ Time Frame: Measured weekly for 6 weeks ]
  • Food craving questionnaire [ Time Frame: Measured daily for 6 weeks ]
  • Side effects questionnaire [ Time Frame: Measured weekly for 6 weeks ]
  • Adherence questionnaire [ Time Frame: Measured weekly for 6 weeks ]
  • Profile of Mood States [ Time Frame: Measured at baseline, 1 hour after light treatment, and weekly for 6 weeks ]
  • Beck Depression Inventory-II (BDI) [ Time Frame: Measured at baseline, 1 hour after light treatment, and weekly for 6 weeks ]

Enrollment: 41
Study Start Date: November 2007
Study Completion Date: August 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A
Participants will be given a 1-hour lab test of bright light treatment, then the bright light treatment for 6 weeks.
Device: Bright light
One hour of exposure to bright light daily upon awakening for 6 weeks.
Other Name: Brite light III light box (Apollo) 10,000 lux.
B
Participants will be given a 1-hour treatment of the red light placebo, then the bright light treatment for 6 weeks.
Device: Red light placebo
One hour of exposure to red light.
Other Name: Dim red light box (Apollo) 50 lux.

Detailed Description:

The winter subtype of seasonal affective disorder (SAD) is characterized by episodes of major depression in the fall and winter, with remission of these episodes in the spring and summer. SAD disrupts the lives of millions of Americans, who experience symptoms such as restless agitation, increased appetite and weight gain, and reduced energy and motivation. Bright light treatment, while shown to be effective in improving SAD in 75% of cases, only causes a full remission in 50% of cases. If doctors had a diagnostic tool to determine which patients would respond to bright light therapy, they could make better decisions about whether to prescribe bright light as treatment. This study will examine a possible diagnostic tool—a single, 1-hour bright light session—for predicting improvement in SAD symptoms over an extended course of bright light treatment. Additionally, because many symptoms of SAD (like weight gain and sedentary lifestyle) correspond to cardiovascular risk, this study will examine whether bright light treatment correlates with improved cardiovascular health.

Participants with SAD will be randomly assigned to first receive a 1-hour session of either bright light or the placebo, red light. Then all participants will switch and receive a 1-hour session of the other type of light. Red light has been accepted as a placebo in previous SAD studies because it does not suppress melatonin or shift circadian rhythms. Before and after each light session, participants will have their SAD symptoms evaluated in a clinical interview and self-report measure. After these two light sessions, all participants will receive instructions for administering bright light treatment on their own at home. For the next 6 weeks, participants will administer the bright light to themselves for 1 hour every morning. Every week they will undergo clinical interviews by phone and will mail in self-report measures, some completed daily and some weekly, to the researchers. The participants will have checkups and interviews in person on Weeks 4 and 6. At the two time periods, SAD symptoms and indicators of cardiovascular risk, such as appetite and sleep loss, will be evaluated. The participant responses to bright light and red light at the initial session will be compared with the participant responses to the subsequent 6-week treatment.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with history of recurrent winter depression
Criteria

Inclusion Criteria:

  • Current major depressive disorder, by structured diagnostic interview (SCID), or current bipolar II disorder, if no prior history of rapid cycling, by SCID
  • Prior history of major depressive disorder or bipolar II disorder with seasonal specifier, by SCID
  • Score of 21 or greater on Hamilton Rating Scale for Depression - Seasonal Affective Disorder Version (SIGH-SAD), met at three time points (informed consent session, 24 hours prior to first light therapy session, and at first light therapy session)

Exclusion Criteria:

  • Current bipolar I disorder, psychotic disorder, or cognitive disorder, by SCID
  • Illicit drug use in the past year, by self-report, or alcohol abuse by SCID
  • History of systemic lupus erythematosus
  • History of heart attack or stroke
  • No antidepressant, mood stabilizer, or antipsychotic medication treatment 30 days before treatment
  • Current occupation involves shift work
  • Current sensitivity to bright light or vision problems not correctable by glasses, by self-report
  • Inability to distinguish colors or see stars at night because of increased light sensitivity, by self-report
  • Current suicidal ideation, by self-report during SCID interview
  • Women of childbearing potential who are pregnant, nursing, or trying to become pregnant. Female participants of childbearing potential must agree to one of the following types of birth control: oral, transdermal, or implantable hormonal contraceptives; intrauterine device; diaphragm plus spermicide; or female condom plus spermicide.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00742365


Sponsors and Collaborators
University of Maryland
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Teodor T. Postolache, MD University of Maryland
  More Information

Responsible Party: University of Maryland
ClinicalTrials.gov Identifier: NCT00742365     History of Changes
Other Study ID Numbers: HP-00043574
R34MH073797 ( U.S. NIH Grant/Contract )
DSIR 83-ATSO
H-28845
First Submitted: August 25, 2008
First Posted: August 27, 2008
Last Update Posted: April 4, 2017
Last Verified: March 2017

Keywords provided by University of Maryland:
Seasonal Affective Disorder
Light Therapy
Seasonal Depression
Psychiatric Disorder
Bright Light
Major Depressive Disorder
Bipolar Disorder

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