Duloxetine for the Treatment of Postpartum Depression

Major Depressive Disorder Clinical Trial

— DuloxPPD  

Official title:

Duloxetine in the Treatment of Postpartum-onset and Non-Postpartum Onset Major Depressive Disorder

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00617045
• Other study ID #: HIC0609001827-Lilly-Duloxetine
• Secondary ID: F1J-US-X043
• Status: Withdrawn
• Phase: N/A
• First received: February 4, 2008
• Last updated: June 15, 2016
• Start date: July 2007
• Est. completion date: May 2013

Study information

• Verified date: June 2016
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

Study was terminated because of poor enrollment

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder
• Postpartum Depression

Intervention

Drug:
• duloxetine
Total treatment period is 12 weeks 30mg po qd times 1 week 60mg po qd times 11 weeks

Locations

Country	Name	City	State
United States	Perinatal & Postpartum Research Program 142 Temple ST Suite 301	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in depression severity compared to baseline scores on the IDS-C between the two subject groups.		12 weeks	Yes