Light Therapy for Depression During Pregnancy

January 5, 2010 updated by: Psychiatric Hospital of the University of Basel

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • BS
      • Basel, BS, Switzerland, 4031
        • Psychiatric Policlinic of the University of Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Psychiatric Hospital of the University of Basel

Collaborators

Columbia University
University of Pittsburgh
Velux Fonden
Basel Women's University Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (ACTUAL)

October 1, 2008

Study Completion (ACTUAL)

October 1, 2008

Study Registration Dates

First Submitted

January 5, 2010

First Submitted That Met QC Criteria

January 5, 2010

First Posted (ESTIMATE)

January 6, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

January 6, 2010

Last Update Submitted That Met QC Criteria

January 5, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPK-2004
  • 3100A0-102190/1, 320000-114110 (OTHER_GRANT: SNF)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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