Status:
WITHDRAWN
Duloxetine for the Treatment of Postpartum Depression
Lead Sponsor:
Yale University
Conditions:
Postpartum Depression
Major Depressive Disorder
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to assess whether the antidepressant, duloxetine, is equally effective as a treatment for subjects who have a Postpartum Onset Depression compared to subjects who have an ...
Detailed Description
Study was terminated because of poor enrollment
Eligibility Criteria
Inclusion
- adult female subjects age 18 and above if onset of depression within 4 weeks of delivery,or onset of depression antenatally either during pregnancy or before pregnancy
- must score greater than or equal to 12 on the Edinburgh Postnatal Depression Scale
- speak English or Spanish
- have access to a telephone
- provide written and verbal consent
Exclusion
- have current or lifetime psychosis
- an unstable medical condition
- hypertension
- narrow-angle glaucoma
- liver disease
- seizure disorders
- bulimia
- anorexia
- mania
- substance abuse disorders
- have a known hypersensitivity to duloxetine or any of the active ingredients
- are in need of inpatient hospital treatment with an excluded medication
- adolescents under the age of 18
- Medication Exclusion
- other antidepressants
- antipsychotic agents
- quinolone antibiotics
- Type 1C antiarrhythmics
- daily benzodiazepines
- Treatment with a monoamine oxidase inhibitor
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00617045
Start Date
July 1 2007
End Date
May 1 2013
Last Update
June 17 2016
Active Locations (1)
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1
Perinatal & Postpartum Research Program 142 Temple ST Suite 301
New Haven, Connecticut, United States, 06510