Duloxetine for the Treatment of Postpartum Depression (DuloxPPD)

June 15, 2016 updated by: Kimberly Yonkers, Yale University

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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Study was terminated because of poor enrollment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Perinatal & Postpartum Research Program 142 Temple ST Suite 301

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Duloxetine
type of experimental agent
Drug: duloxetine

Total treatment period is 12 weeks

30mg po qd times 1 week

60mg po qd times 11 weeks

Other Names:
  • Cymbalta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in depression severity compared to baseline scores on the IDS-C between the two subject groups.
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Investigators

  • Principal Investigator: Kimberly A Yonkers, MD, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

February 4, 2008

First Submitted That Met QC Criteria

February 14, 2008

First Posted (Estimate)

February 15, 2008

Study Record Updates

Last Update Posted (Estimate)

June 17, 2016

Last Update Submitted That Met QC Criteria

June 15, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIC0609001827-Lilly-Duloxetine
  • F1J-US-X043 (Other Grant/Funding Number: Eli Lilly Pharmaceutical)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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