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Light Therapy for Depression During Pregnancy

Primary Purpose

Major Depressive Disorder, Pregnancy

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Light therapy
Sponsored by
Psychiatric Hospital of the University of Basel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring light therapy, antepartum depression, controlled trial

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Psychiatric Policlinic of the University of Basel

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bright light therapy

Dim red light

Arm Description

Early morning white light @ 7,000 lux for 60 minutes daily (4.2 x 10^5 lux-min) for 5 weeks

Early morning dim red light @ 70 lux for 60 minutes daily (3.0 x 10^3 lux-min) for 5 weeks

Outcomes

Primary Outcome Measures

Change in depression ratings (HAMD, SIGH-ADS)

Secondary Outcome Measures

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

Full Information

First Posted
January 5, 2010
Last Updated
January 5, 2010
Sponsor
Psychiatric Hospital of the University of Basel
Collaborators
Basel Women's University Hospital, Columbia University, University of Pittsburgh, Velux Fonden
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1. Study Identification

Unique Protocol Identification Number
NCT01043289
Brief Title
Light Therapy for Depression During Pregnancy
Official Title
A Randomised, Double-blind, Placebo-controlled Study of Light Therapy for Antepartum Depression
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Psychiatric Hospital of the University of Basel
Collaborators
Basel Women's University Hospital, Columbia University, University of Pittsburgh, Velux Fonden

4. Oversight

Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Pregnancy
Keywords
light therapy, antepartum depression, controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bright light therapy
Arm Type
Experimental
Arm Description
Early morning white light @ 7,000 lux for 60 minutes daily (4.2 x 10^5 lux-min) for 5 weeks
Arm Title
Dim red light
Arm Type
Placebo Comparator
Arm Description
Early morning dim red light @ 70 lux for 60 minutes daily (3.0 x 10^3 lux-min) for 5 weeks
Intervention Type
Other
Intervention Name(s)
Light therapy
Other Intervention Name(s)
Phototherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in depression ratings (HAMD, SIGH-ADS)
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
Effect of light therapy on circadian rhythms (e.g. melatonin, rest-activity cycle)
Time Frame
5 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Wirz-Justice, PhD
Organizational Affiliation
Psychiatric Hospital of the University of Basel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psychiatric Policlinic of the University of Basel
City
Basel
State/Province
BS
ZIP/Postal Code
4031
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
15096083
Citation
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. doi: 10.4088/jcp.v65n0319.
Results Reference
background
PubMed Identifier
11925310
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. doi: 10.1176/appi.ajp.159.4.666.
Results Reference
background
PubMed Identifier
21535997
Citation
Wirz-Justice A, Bader A, Frisch U, Stieglitz RD, Alder J, Bitzer J, Hosli I, Jazbec S, Benedetti F, Terman M, Wisner KL, Riecher-Rossler A. A randomized, double-blind, placebo-controlled study of light therapy for antepartum depression. J Clin Psychiatry. 2011 Jul;72(7):986-93. doi: 10.4088/JCP.10m06188blu. Epub 2011 Apr 5.
Results Reference
derived
Links:
URL
http://www.cet.org
Description
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
URL
http://www.sltbr.org
Description
Society for Light Treatment and Biological Rhythms

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Light Therapy for Depression During Pregnancy

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