Light Therapy for Depression During Pregnancy

• ClinicalTrials.gov Identifier: NCT01043289
• Recruitment Status: Completed
• First Posted: January 6, 2010
• Last Update Posted: January 6, 2010
• Sponsor: Psychiatric Hospital of the University of Basel
• Collaborators: Basel Women's University Hospital; Columbia University; University of Pittsburgh; Velux Fonden
• Information provided by: Psychiatric Hospital of the University of Basel

Study Description

Brief Summary:

The purpose of this study is to determine whether morning bright light therapy is an effective treatment for major depression during pregnancy compared with low-intensity placebo light therapy, when administered 60 minutes daily for 5 weeks.

Condition or disease	Intervention/treatment	Phase
Major Depressive Disorder; Pregnancy	Other: Light therapy	Not Applicable

Detailed Description:

Affective disorder during pregnancy is a common and severe condition, associated with a higher risk for prenatal complications, preterm delivery, a higher rate of surgical birth and vaginal operative delivery. Depressed pregnant women are at risk for inadequate nutrition, poor weight gain, increased use of nicotine, drugs and alcohol, and failure to obtain adequate prenatal care, as well as poor mother-child attachment. Their infants have a higher risk for low birth weight, a higher rate of admission to neonatal intensive care, and cognitive, emotional and behavioural disturbances.Treatment of antepartum depression requires careful judgement to minimise risk to the foetus. Pharmacological treatment is an option, but all antidepressants cross the placenta, and both practitioners and patients are concerned about possible teratogenicity, pre- and perinatal adverse effects for the infant, as well as negative effects on long-term development. Thus, psychiatric medication use for depression in pregnancy may also pose an excess risk of preterm delivery and withdrawal symptoms in the newborn. Treatment of depression during pregnancy that is efficacious, reliable, safe, and with minor side effects is an urgent unmet clinical need. Light therapy may provide this somatic, non-pharmaceutical alternative. It is well established as the treatment of choice for Seasonal Affective Disorder (SAD), and there is a growing data base for response in nonseasonal major depression. Two promising pilot studies led to the present randomised, double-blind, placebo-controlled trial of 5 weeks daily morning bright light therapy (1h, 7000 lux white) compared with low-intensity placebo light therapy (1h, 70 lux red).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 46 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomised, Double-blind, Placebo-controlled Study of Light Therapy for Antepartum Depression
• Study Start Date: October 2004
• Actual Primary Completion Date: October 2008
• Actual Study Completion Date: October 2008

Arms and Interventions

Arm	Intervention/treatment
Experimental: Bright light therapy; Early morning white light @ 7,000 lux for 60 minutes daily (4.2 x 10^5 lux-min) for 5 weeks	Other: Light therapy; During the 5-week treatment period, subjects sit in front of a light box for 60 minutes daily after awakening, at a specified distance that provides the required light intensity.; Other Name: Phototherapy
Placebo Comparator: Dim red light; Early morning dim red light @ 70 lux for 60 minutes daily (3.0 x 10^3 lux-min) for 5 weeks	Other: Light therapy; During the 5-week treatment period, subjects sit in front of a light box for 60 minutes daily after awakening, at a specified distance that provides the required light intensity.; Other Name: Phototherapy

Outcome Measures

Primary Outcome Measures :

1. Change in depression ratings (HAMD, SIGH-ADS) [ Time Frame: 5 weeks ]

Secondary Outcome Measures :

1. Effect of light therapy on circadian rhythms (e.g. melatonin, rest-activity cycle) [ Time Frame: 5 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• German-speaking
• Medically healthy with normal ocular function
• Pregnancy 4 through 32 weeks gestation based on first trimester ultrasound
• DSM-IV diagnosis of major depressive disorder
• SIGH-ADS [Structured Interview Guide for the Hamilton Depression Rating Scale (HAMD) with Atypical Depression Supplement] score of >20
• Able to provide informed consent
• Preferably untreated; exception when on antidepressant for more than 3 months without any improvement, keeping medication constant during the study

Exclusion Criteria:

• DSM-IV diagnoses of bipolar 1 or 2 disorder or any psychotic episode
• Substance abuse within the last 6 months
• Primary anxiety disorder
• Recent history of suicide attempt (6 months)
• Delayed sleep phase disorder or hypersomnia with habitual sleep onset later than 1 a.m. or wakening later than 9 a.m.
• Obstetrical care or medications for medical disorders which might confound treatment results
• Fetal malformations and intrauterine fetal death

Contacts and Locations

Locations

Switzerland

Psychiatric Policlinic of the University of Basel

Basel, BS, Switzerland, 4031

Sponsors and Collaborators

Psychiatric Hospital of the University of Basel

Basel Women's University Hospital

Columbia University

University of Pittsburgh

Velux Fonden

Investigators

• Principal Investigator: Anna Wirz-Justice, PhD; Psychiatric Hospital of the University of Basel

More Information

Additional Information:

The Center for Environmental Therapeutics is a 501(c)(3) nonprofit organization made up of a multidisciplinary team of researchers and clinicians for the development and application of effective environmental therapies 

Society for Light Treatment and Biological Rhythms 

Publications:

Epperson CN, Terman M, Terman JS, Hanusa BH, Oren DA, Peindl KS, Wisner KL. Randomized clinical trial of bright light therapy for antepartum depression: preliminary findings. J Clin Psychiatry. 2004 Mar;65(3):421-5. doi: 10.4088/jcp.v65n0319.

Oren DA, Wisner KL, Spinelli M, Epperson CN, Peindl KS, Terman JS, Terman M. An open trial of morning light therapy for treatment of antepartum depression. Am J Psychiatry. 2002 Apr;159(4):666-9. doi: 10.1176/appi.ajp.159.4.666.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wirz-Justice A, Bader A, Frisch U, Stieglitz RD, Alder J, Bitzer J, Hosli I, Jazbec S, Benedetti F, Terman M, Wisner KL, Riecher-Rossler A. A randomized, double-blind, placebo-controlled study of light therapy for antepartum depression. J Clin Psychiatry. 2011 Jul;72(7):986-93. doi: 10.4088/JCP.10m06188blu. Epub 2011 Apr 5.

• Responsible Party: Wirz-Justice, Anna / Professor, Centre for Chronobiology, Psychiatric Hospital of the University of Basel
• ClinicalTrials.gov Identifier: NCT01043289
• Other Study ID Numbers: UPK-2004; 3100A0-102190/1, 320000-114110 ( Other Grant/Funding Number: SNF )
• First Posted: January 6, 2010
• Last Update Posted: January 6, 2010
• Last Verified: January 2010

Keywords provided by Psychiatric Hospital of the University of Basel:

light therapy; antepartum depression; controlled trial

Additional relevant MeSH terms:

Depression; Depressive Disorder; Depressive Disorder, Major; Behavioral Symptoms; Mood Disorders; Mental Disorders