Light Therapy for Depression During Pregnancy

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Major Depressive Disorder, Pregnancy

Intervention / Treatment
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* Other: Light therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bright light therapy<br>Early morning white light @ 7,000 lux for 60 minutes daily (4.2 x 10^5 lux-min) for 5 weeks | Other: Light therapy<br>* 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.<br>* Other names: Phototherapy;|
| Placebo Comparator: Dim red light<br>Early morning dim red light @ 70 lux for 60 minutes daily (3.0 x 10^3 lux-min) for 5 weeks | Other: Light therapy<br>* 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.<br>* Other names: Phototherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depression ratings (HAMD, SIGH-ADS) |  | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of light therapy on circadian rhythms (e.g. melatonin, rest-activity cycle) |  | 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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light therapy, antepartum depression, controlled trial