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

February 4, 2008
July 8, 2014
July 2007
December 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00617045 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Duloxetine for the Treatment of Postpartum Depression
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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Postpartum Depression
  • Major Depressive Disorder
Drug: duloxetine

Total treatment period is 12 weeks

30mg po qd times 1 week

60mg po qd times 11 weeks

Other Name: Cymbalta
Active Comparator: Duloxetine
Open label duloxetine
Intervention: Drug: duloxetine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
May 2013
December 2012   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00617045
HIC0609001827-Lilly-Duloxetine, F1J-US-X043
No
Kimberly Yonkers, Yale University
Yale University
Not Provided
Principal Investigator: Kimberly A Yonkers, MD Yale University
Yale University
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP