A Comparison of Antidepressant Treatment in Women With and Without Postpartum Onset of Major Depressive Disorder - Full Text View

A Comparison of Antidepressant Treatment in Women With and Without Postpartum Onset of Major Depressive Disorder (P&BMOMS)

This study is currently recruiting participants.

Verified by Yale University, February 2008

First Received: February 4, 2008 Last Updated: February 14, 2008 History of Changes

Sponsored by:	Yale University
Information provided by:	Yale University
ClinicalTrials.gov Identifier:	NCT00617045

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:	Treatment, Open Label, Single Group Assignment, Efficacy Study
Official Title:	Duloxetine in the Treatment of Postpartum-Onset and Non-Postpartum Onset Major Depressive Disorder

Resource links provided by NLM:

MedlinePlus related topics: Antidepressants Depression Postpartum Care Postpartum Depression

Drug Information available for: Duloxetine Duloxetine hydrochloride

U.S. FDA Resources

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 ]

Estimated Enrollment:	50
Study Start Date:	July 2007
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Intervention Details:

Total treatment period is 12 weeks

30mg po qd times 1 week

60mg po qd times 11 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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
are breastfeeding
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

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

Contacts

Contact: Susan P Good, RN,MS

203-764-6764

susan.good@yale.edu

Locations

United States, Connecticut
Perinatal & Postpartum Research Program 142 Temple ST Suite 301	Recruiting
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:	Yale University ( Dr. Kimberly A Yonkers )
Study ID Numbers:	HIC0609001827-Lilly-Duloxetine, F1J-US-X043
Study First Received:	February 4, 2008
Last Updated:	February 14, 2008
ClinicalTrials.gov Identifier:	NCT00617045 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Yale University:

Post Partum Major Depressive Disorder

Study placed in the following topic categories:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Depression
Pregnancy Complications
Adrenergic Agents
Psychotropic Drugs
Depressive Disorder, Major
Depressive Disorder
Serotonin Uptake Inhibitors
Duloxetine

Serotonin
Behavioral Symptoms
Dopamine
Depression, Postpartum
Puerperal Disorders
Mental Disorders
Mood Disorders
Dopamine Agents
Antidepressive Agents

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Pregnancy Complications
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs
Depressive Disorder, Major
Duloxetine
Pathologic Processes
Puerperal Disorders
Depression, Postpartum

Mental Disorders
Therapeutic Uses
Antidepressive Agents
Disease
Depression
Depressive Disorder
Serotonin Uptake Inhibitors
Pharmacologic Actions
Behavioral Symptoms
Serotonin Agents
Mood Disorders
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 10, 2009