Duloxetine for the Treatment of Postpartum Depression

Not Applicable

Withdrawn

• Conditions: Postpartum Depression; Major Depressive Disorder
• Interventions: Drug: duloxetine

• Registration Number: NCT00617045
• Lead Sponsor: Yale University

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 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.

Detailed Description

Study was terminated because of poor enrollment

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2008-02-04
• Study First Submitted QC: 2008-02-14
• Study First Posted: 2008-02-15
• Primary Completion: 2012-12
• Study Completion: 2013-05
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-15
• Last Update Posted: 2016-06-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Duloxetine	duloxetine	type of experimental agent

Primary Outcome Measures

Name	Time	Method
Change in depression severity compared to baseline scores on the IDS-C between the two subject groups.	12 weeks

Trial Locations

Locations (1)

Perinatal & Postpartum Research Program 142 Temple ST Suite 301; 🇺🇸 New Haven, Connecticut, United States