Duloxetine for the Treatment of Postpartum Depression
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 onset of Major Depressive Disorder prior to delivery. The hypothesis is that duloxetine will be as effective in subjects with Postpartum Major Depressive Disorder as in subjects with a Major...
Brief Summary
Official Title: “Duloxetine in the Treatment of Postpartum-onset and Non-Postpartum Onset Major Depressive Disorder”
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 onset of Major Depressive Disorder prior to delivery. The hypothesis is that duloxetine will be as effective in subjects with Postpartum Major Depressive Disorder as in subjects with a Major Depressive Disorder.
- Study Type: Interventional
- Study Design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: December 2012
Intervention(s) in this Clinical Trial
- Drug: duloxetine
- Total treatment period is 12 weeks 30mg po qd times 1 week 60mg po qd times 11 weeks
Outcome Measures for this Clinical Trial
Primary Measures
- Change in depression severity compared to baseline scores on the IDS-C between the two subject groups.
- Time Frame: 12 weeks
Safety Issue?: Yes
- Time Frame: 12 weeks
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- 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 Criteria:
- 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
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Yale University Other
Overall Clinical Trial Officials and Contacts
Kimberly A Yonkers, MD Principal Investigator Yale University
Overall Contact: Heather Howell, MSW 203-764-6764 heather.howell@yale.edu
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00617045
Study ID Number: HIC0609001827-Lilly-Duloxetine
ClinicalTrials.gov Identifier: NCT00617045
Health Authority: United States: Institutional Review Board
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00617045
