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Duloxetine for the Treatment of Postpartum Depression (DuloxPPD)

Primary Purpose

Postpartum Depression, Major Depressive Disorder

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
duloxetine
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postpartum Depression focused on measuring Post Partum Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Perinatal & Postpartum Research Program 142 Temple ST Suite 301

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Duloxetine

Arm Description

type of experimental agent

Outcomes

Primary Outcome Measures

Change in depression severity compared to baseline scores on the IDS-C between the two subject groups.

Secondary Outcome Measures

Full Information

First Posted
February 4, 2008
Last Updated
June 15, 2016
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT00617045
Brief Title
Duloxetine for the Treatment of Postpartum Depression
Acronym
DuloxPPD
Official Title
Duloxetine in the Treatment of Postpartum-onset and Non-Postpartum Onset Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Withdrawn
Why Stopped
poor patient recruitment
Study Start Date
July 2007 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yale University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depression, Major Depressive Disorder
Keywords
Post Partum Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Duloxetine
Arm Type
Experimental
Arm Description
type of experimental agent
Intervention Type
Drug
Intervention Name(s)
duloxetine
Other Intervention Name(s)
Cymbalta
Intervention Description
Total treatment period is 12 weeks 30mg po qd times 1 week 60mg po qd times 11 weeks
Primary Outcome Measure Information:
Title
Change in depression severity compared to baseline scores on the IDS-C between the two subject groups.
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberly A Yonkers, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Perinatal & Postpartum Research Program 142 Temple ST Suite 301
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Duloxetine for the Treatment of Postpartum Depression

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