Predicting Effectiveness of Light Treatment for Winter Seasonal Affective Disorder

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by National Institute of Mental Health (NIMH).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00742365
First received: August 25, 2008
Last updated: January 7, 2011
Last verified: January 2011
  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 National Institute of Mental Health (NIMH):

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Hunger questionnaire [ Time Frame: Measured daily for 6 weeks ] [ Designated as safety issue: No ]
  • Three factor eating questionnaire [ Time Frame: Measured weekly for 6 weeks ] [ Designated as safety issue: No ]
  • Sleep log [ Time Frame: Measured weekly for 6 weeks ] [ Designated as safety issue: No ]
  • Food craving questionnaire [ Time Frame: Measured daily for 6 weeks ] [ Designated as safety issue: No ]
  • Side effects questionnaire [ Time Frame: Measured weekly for 6 weeks ] [ Designated as safety issue: Yes ]
  • Adherence questionnaire [ Time Frame: Measured weekly for 6 weeks ] [ Designated as safety issue: No ]
  • Profile of Mood States [ Time Frame: Measured at baseline, 1 hour after light treatment, and weekly for 6 weeks ] [ Designated as safety issue: No ]
  • Beck Depression Inventory-II (BDI) [ Time Frame: Measured at baseline, 1 hour after light treatment, and weekly for 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: November 2007
Estimated Study Completion Date: September 2011
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

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00742365

Sponsors and Collaborators
Investigators
Principal Investigator: Teodor T. Postolache, MD University of Maryland, Baltimore County
  More Information

No publications provided

Responsible Party: Teodor T. Postolache, Principal Investigator, University of Maryland Baltimore
ClinicalTrials.gov Identifier: NCT00742365     History of Changes
Other Study ID Numbers: R34 MH073797, DSIR 83-ATSO, H-28845
Study First Received: August 25, 2008
Last Updated: January 7, 2011
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Seasonal Affective Disorder
Light Therapy
Seasonal Depression
Psychiatric Disorder
Bright Light
Major Depressive Disorder
Bipolar Disorder

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

ClinicalTrials.gov processed this record on August 21, 2014