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.

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.

Study Type ICMJE

Observational

Study Design ICMJE

Observational Model: CohortTime Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Patients with history of recurrent winter depression

Condition ICMJE

Depression

Intervention ICMJE

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.

Device: Red light placebo

One hour of exposure to red light.

Other Name: Dim red light box (Apollo) 50 lux.

Study Group/Cohort (s)

A

Participants will be given a 1-hour lab test of bright light treatment, then the bright light treatment for 6 weeks.

Intervention: Device: Bright light

B

Participants will be given a 1-hour treatment of the red light placebo, then the bright light treatment for 6 weeks.

Intervention: Device: Red light placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Active, not recruiting

Estimated Enrollment ICMJE

80

Estimated Completion Date

September 2015

Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ICMJE

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.

Gender

Both

Ages

18 Years to 64 Years

Accepts Healthy Volunteers

No

Contacts ICMJE

Contact information is only displayed when the study is recruiting subjects