Predicting Effectiveness of Light Treatment for Winter Seasonal Affective Disorder

NCT00742365 | Completed DMC

• 4 other identifiers: HP-00043574R34MH073797DSIR 83-ATSOH-28845
• Study Type: observational
• Target: 41
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Depression

Keywords

Seasonal Affective Disorder; Light Therapy; Seasonal Depression; Psychiatric Disorder; Bright Light; Major Depressive Disorder; Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

• Hamilton rating scale for depressional seasonal affective disorder (SIGH SAD)

  Measured at baseline, 1 hour after light treatment, and weekly for 6 weeks

Secondary Outcomes (8)

• Hunger questionnaire

  Measured daily for 6 weeks

• Three factor eating questionnaire

  Measured weekly for 6 weeks

• Sleep log

  Measured weekly for 6 weeks

• Food craving questionnaire

  Measured daily for 6 weeks

• Side effects questionnaire

  Measured weekly for 6 weeks

Study Arms (2)

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

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

Interventions

Bright light DEVICE

One hour of exposure to bright light daily upon awakening for 6 weeks.

Also known as: Brite light III light box (Apollo) 10,000 lux.

A

Red light placebo DEVICE

One hour of exposure to red light.

Also known as: Dim red light box (Apollo) 50 lux.

B

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with history of recurrent winter depression

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Institute of Mental Health (NIMH): collaborator

Related Publications (4)

• Uzoma HN, Reeves GM, Langenberg P, Khabazghazvini B, Balis TG, Johnson MA, Sleemi A, Scrandis DA, Zimmerman SA, Vaswani D, Nijjar GV, Cabassa J, Lapidus M, Rohan KJ, Postolache TT. Light treatment for seasonal Winter depression in African-American vs Caucasian outpatients. World J Psychiatry. 2015 Mar 22;5(1):138-46. doi: 10.5498/wjp.v5.i1.138.

  PMID: 25815263 BACKGROUND

• Reeves GM, Rohan KJ, Langenberg P, Snitker S, Postolache TT. Calibration of response and remission cut-points on the Beck Depression Inventory-Second Edition for monitoring seasonal affective disorder treatment outcomes. J Affect Disord. 2012 Apr;138(1-2):123-7. doi: 10.1016/j.jad.2011.12.003. Epub 2012 Jan 25.

  PMID: 22277151 BACKGROUND

• Reeves GM, Nijjar GV, Langenberg P, Johnson MA, Khabazghazvini B, Sleemi A, Vaswani D, Lapidus M, Manalai P, Tariq M, Acharya M, Cabassa J, Snitker S, Postolache TT. Improvement in depression scores after 1 hour of light therapy treatment in patients with seasonal affective disorder. J Nerv Ment Dis. 2012 Jan;200(1):51-5. doi: 10.1097/NMD.0b013e31823e56ca.

  PMID: 22210362 BACKGROUND

• Virk G, Reeves G, Rosenthal NE, Sher L, Postolache TT. Short exposure to light treatment improves depression scores in patients with seasonal affective disorder: A brief report. Int J Disabil Hum Dev. 2009 Jul;8(3):283-286. doi: 10.1901/jaba.2009.8-283.

  PMID: 20686638 BACKGROUND

MeSH Terms

Conditions

Depression; Seasonal Affective Disorder; Mental Disorders; Depressive Disorder, Major; Bipolar Disorder

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Bipolar and Related Disorders

Study Officials

• Teodor T. Postolache, MD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 25, 2008
• First Posted: August 27, 2008
• Study Start: November 1, 2007
• Primary Completion: April 1, 2010
• Study Completion: August 1, 2010
• Last Updated: November 21, 2019

Record last verified: 2019-11