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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00833469 |
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Date of registration:
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29/01/2009 |
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Primary sponsor: |
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Public title:
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Escitalopram (Lexapro) for the Treatment of Postpartum Depression
LexaproPPD |
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Scientific title:
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Escitalopram for the Treatment of Postpartum Depression |
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Date of first enrolment:
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January 2009 |
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Target sample size:
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20 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00833469 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Marlene P Freeman, MD |
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Address:
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Telephone:
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617-643-6403 |
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Email:
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mfreeman@partners.org |
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Affiliation:
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Name:
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Stephanie D Connors, BS |
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Address:
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Telephone:
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617-724-6989 |
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Email:
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sdconnors@partners.org |
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Affiliation:
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Name:
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Marlene P Freeman, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Massachusetts General Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Women ages 18 to 45 years old
- Subjects must meet criteria for a major depressive episode with symptoms developing
within three month of live childbirth
- Subjects must present within six months of childbirth
- MADRS score >15
- BAI score >10
- Subjects will be able to be treated on an outpatient basis
- Subjects will be able to provide written informed consent
Exclusion Criteria:
- Subjects who have taken any psychotropic medication, including antidepressants and
anti-anxiety medication, within the past two weeks (with the exception of
non-benzodiazepine medications used for sleep, including trazodone, zolpidem,
eszopiclone, etc)
- Suicidal ideation with active plan or intent, as determined by the investigator
- Presence of psychotic symptoms or homicidal ideation
- History of mania or hypomania
- Pregnant or breastfeeding
- Presence of chronic depression or dysthymia, or chronic or treatment resistant
anxiety disorders, as determined by investigator
- Active alcohol/substance abuse currently or within the past year
- Abnormal TSH, severe anemia, or uncontrolled hypertension
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Postpartum Depression
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Intervention(s)
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Drug: Escitalopram
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Primary Outcome(s)
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Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS)
[Time Frame: 8 weeks]
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Secondary Outcome(s)
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Edinburgh Postnatal Depression Scale (EPDS)
[Time Frame: 8 weeks]
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Secondary ID(s)
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2008-P-001509
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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