Light Therapy for Depression During Pregnancy

Sponsor

Psychiatric Hospital of the University of Basel (Other)

Overall Status

Completed

CT.gov ID

NCT01043289

Collaborator

Basel Women's University Hospital (Other), Columbia University (Other), University of Pittsburgh (Other), Velux Fonden (Other)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

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	N/A

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

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 :

Oct 1, 2004

Actual Primary Completion Date :

Oct 1, 2008

Actual Study Completion Date :

Oct 1, 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 Names: 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 Names: Phototherapy

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 Names:

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 Names:

Phototherapy

Outcome Measures

Primary Outcome Measures

Change in depression ratings (HAMD, SIGH-ADS) [5 weeks]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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