NCT01043289

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable major-depressive-disorder

Timeline
Completed

Started Oct 2004

Longer than P75 for not_applicable major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 6, 2010

Completed
Last Updated

January 6, 2010

Status Verified

January 1, 2010

Enrollment Period

4 years

First QC Date

January 5, 2010

Last Update Submit

January 5, 2010

Conditions

Major Depressive DisorderPregnancy

Keywords

light therapyantepartum depressioncontrolled trial

Outcome Measures

Primary Outcomes (1)

  • Change in depression ratings (HAMD, SIGH-ADS)

    5 weeks

Secondary Outcomes (1)

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

    5 weeks

Study Arms (2)

Bright light therapy

EXPERIMENTAL

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

Other: Light therapy

Dim red light

PLACEBO COMPARATOR

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

Other: Light therapy

Interventions

Light therapyOTHER

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.

Also known as: Phototherapy
Bright light therapyDim red light

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychiatric Policlinic of the University of Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

Related Publications (3)

  • 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.

    PMID: 15096083BACKGROUND

  • 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.

    PMID: 11925310BACKGROUND

  • 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.

    PMID: 21535997DERIVED

Related Links

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Anna Wirz-Justice, PhD

    Psychiatric Hospital of the University of Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 5, 2010

First Posted

January 6, 2010

Study Start

October 1, 2004

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

January 6, 2010

Record last verified: 2010-01

Locations

CH(1)