Light Therapy for Depression During Pregnancy

This study has been completed.
Sponsor:
Collaborators:
Basel Women’s University Hospital
Columbia University
University of Pittsburgh
Velux Fonden
Information provided by:
Psychiatric Hospital of the University of Basel
ClinicalTrials.gov Identifier:
NCT01043289
First received: January 5, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

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 Intervention
Major Depressive Disorder
Pregnancy
Other: Light therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled Study of Light Therapy for Antepartum Depression

Resource links provided by NLM:


Further study details as provided by Psychiatric Hospital of the University of Basel:

Primary Outcome Measures:
  • Change in depression ratings (HAMD, SIGH-ADS) [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effect of light therapy on circadian rhythms (e.g. melatonin, rest-activity cycle) [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: October 2004
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01043289

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:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wirz-Justice, Anna / Professor, Centre for Chronobiology, Psychiatric Hospital of the University of Basel
ClinicalTrials.gov Identifier: NCT01043289     History of Changes
Other Study ID Numbers: UPK-2004, 3100A0-102190/1, 320000-114110
Study First Received: January 5, 2010
Last Updated: January 5, 2010
Health Authority: Switzerland: Swissmedic

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

ClinicalTrials.gov processed this record on September 11, 2014