Duloxetine for the Treatment of Postpartum Depression (DuloxPPD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kimberly Yonkers, Yale University
ClinicalTrials.gov Identifier:
NCT00617045
First received: February 4, 2008
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Postpartum Depression
Major Depressive Disorder
Drug: duloxetine

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Duloxetine in the Treatment of Postpartum-onset and Non-Postpartum Onset Major Depressive Disorder

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Change in depression severity compared to baseline scores on the IDS-C between the two subject groups. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 14
Study Start Date: July 2007
Study Completion Date: May 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Duloxetine
Open label duloxetine
Drug: duloxetine

Total treatment period is 12 weeks

30mg po qd times 1 week

60mg po qd times 11 weeks

Other Name: Cymbalta

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00617045

Locations
United States, Connecticut
Perinatal & Postpartum Research Program 142 Temple ST Suite 301
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Kimberly A Yonkers, MD Yale University
  More Information

No publications provided

Responsible Party: Kimberly Yonkers, Professor, Yale University
ClinicalTrials.gov Identifier: NCT00617045     History of Changes
Other Study ID Numbers: HIC0609001827-Lilly-Duloxetine, F1J-US-X043
Study First Received: February 4, 2008
Last Updated: July 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Post Partum Depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Depression, Postpartum
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications
Duloxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents
Dopamine Uptake Inhibitors
Dopamine Agents
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014