Duloxetine for the Treatment of Postpartum Depression

NCT00617045 | Withdrawn

• 2 other identifiers: HIC0609001827-Lilly-DuloxetineF1J-US-X043
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Depression; Major Depressive Disorder

Keywords

Post Partum Depression

Outcome Measures

Primary Outcomes (1)

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

  12 weeks

Study Arms (1)

Duloxetine

EXPERIMENTAL

type of experimental agent

Drug: duloxetine

Interventions

duloxetine DRUG

Total treatment period is 12 weeks 30mg po qd times 1 week 60mg po qd times 11 weeks

Also known as: Cymbalta

Duloxetine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• other antidepressants
• antipsychotic agents

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Perinatal & Postpartum Research Program 142 Temple ST Suite 301

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Depression, Postpartum; Depressive Disorder, Major

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Kimberly A Yonkers, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 4, 2008
• First Posted: February 15, 2008
• Study Start: July 1, 2007
• Primary Completion: December 1, 2012
• Study Completion: May 1, 2013
• Last Updated: June 17, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)