Light Therapy for Depression During Pregnancy
| Tracking Information | |||||
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| First Received Date ICMJE | January 5, 2010 | ||||
| Last Updated Date | January 5, 2010 | ||||
| Start Date ICMJE | October 2004 | ||||
| Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Change in depression ratings (HAMD, SIGH-ADS) [ Time Frame: 5 weeks ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
Effect of light therapy on circadian rhythms (e.g. melatonin, rest-activity cycle) [ Time Frame: 5 weeks ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Light Therapy for Depression During Pregnancy | ||||
| Official Title ICMJE | A Randomised, Double-blind, Placebo-controlled Study of Light Therapy for Antepartum Depression | ||||
| 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. |
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| 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). |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | 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 |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 46 | ||||
| Completion Date | October 2008 | ||||
| Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 45 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Switzerland | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01043289 | ||||
| Other Study ID Numbers ICMJE | UPK-2004, 3100A0-102190/1, 320000-114110 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Wirz-Justice, Anna / Professor, Centre for Chronobiology, Psychiatric Hospital of the University of Basel | ||||
| Study Sponsor ICMJE | Psychiatric Hospital of the University of Basel | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Psychiatric Hospital of the University of Basel | ||||
| Verification Date | January 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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