Overview

This trial is active, not recruiting.

Condition depression
Treatments bright light, red light placebo
Sponsor University of Maryland
Collaborator National Institute of Mental Health (NIMH)
Start date November 2007
End date April 2010
Trial size 80 participants
Trial identifier NCT00742365, DSIR 83-ATSO, H-28845, R34 MH073797, R34MH073797

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Participants will be given a 1-hour lab test of bright light treatment, then the bright light treatment for 6 weeks.
bright light Brite light III light box (Apollo) 10,000 lux.
One hour of exposure to bright light daily upon awakening for 6 weeks.
Participants will be given a 1-hour treatment of the red light placebo, then the bright light treatment for 6 weeks.
red light placebo Dim red light box (Apollo) 50 lux.
One hour of exposure to red light.

Primary Outcomes

Measure
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 Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 64 years old.

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.

Additional Information

Official title Predicting Light Treatment's Effectiveness on Reducing Depression and Cardiovascular Risk in Seasonal Affective Disorder
Principal investigator Teodor T. Postolache, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by University of Maryland.