Predicting Effectiveness of Light Treatment for Winter Seasonal Affective Disorder - Full Text View

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00742365

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

MedlinePlus related topics: Depression Mental Health Seasonal Affective Disorder

U.S. FDA Resources

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

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	80
Study Start Date:	November 2007
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	January 2009 (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.
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.

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

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

Contacts

Contact: Manana Lapidus, MD	410-706-2323	mlapidus@psych.umaryland.edu
Contact: Johanna A. Cabassa, MD	410-706-2323	jcabassa@psych.umaryland.edu

Locations

United States, Maryland
University of Maryland	Active, not recruiting
Baltimore, Maryland, United States, 21201
University of Maryland School of Medicine, MAP	Recruiting
Baltimore, Maryland, United States, 21201
Contact: Manana Lapidus, MD 410-706-2323 mlapidus@psych.umaryland.edu
Principal Investigator: Teodor T. Postolache, MD

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Teodor T. Postolache, MD

University of Maryland

More Information

Responsible Party:	University of Maryland Baltimore ( Teodor T. Postolache, Principal Investigator )
Study ID Numbers:	R34 MH073797, DSIR 83-ATSO, H-28845
Study First Received:	August 25, 2008
Last Updated:	September 10, 2008
ClinicalTrials.gov Identifier:	NCT00742365
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

Study placed in the following topic categories:

Seasonal Affective Disorder
Depression
Mental Disorders
Bipolar Disorder

Mood Disorders
Depressive Disorder, Major
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on January 30, 2009