Light Therapy for Depression During Pregnancy

Major Depressive Disorder Clinical Trial

Official title:

A Randomised, Double-blind, Placebo-controlled Study of Light Therapy for Antepartum Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01043289
• Other study ID #: UPK-2004
• Secondary ID: 3100A0-102190/1,
• Status: Completed
• Phase: N/A
• First received: January 5, 2010
• Last updated: January 5, 2010
• Start date: October 2004
• Est. completion date: October 2008

Study information

• Verified date: January 2010
• Source: Psychiatric Hospital of the University of Basel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder
• Pregnancy

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Psychiatric Policlinic of the University of Basel	Basel	BS

Sponsors (5)

Lead Sponsor	Collaborator
Psychiatric Hospital of the University of Basel	Basel Women’s University Hospital, Columbia University, University of Pittsburgh, Velux Fonden

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in depression ratings (HAMD, SIGH-ADS)		5 weeks	No
Secondary	Effect of light therapy on circadian rhythms (e.g. melatonin, rest-activity cycle)		5 weeks	No

External Links

•   Society for Light Treatment and Biological Rhythms
•   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