- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00617045
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Withdrawn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
-
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Connecticut
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New Haven, Connecticut, United States, 06510
- Perinatal & Postpartum Research Program 142 Temple ST Suite 301
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-
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
|
Total treatment period is 12 weeks 30mg po qd times 1 week 60mg po qd times 11 weeks
Other Names:
|
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
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
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Pregnancy Complications
- Puerperal Disorders
- Depression
- Depressive Disorder
- Depression, Postpartum
- Depressive Disorder, Major
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Dopamine Agents
- Serotonin and Noradrenaline Reuptake Inhibitors
- Duloxetine Hydrochloride
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.
Clinical Trials on Postpartum Depression
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University of British ColumbiaCanadian Institutes of Health Research (CIHR); Women's Health Research Institute...CompletedPostpartum Depression | Perinatal Disorder | Postpartum Disorder | Perinatal Depression | Postpartum Anxiety | Postnatal DepressionCanada
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University of CoimbraEnrolling by invitationPostPartum DepressionPortugal
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University of MinnesotaNational Institute of Mental Health (NIMH)Completed
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Sage TherapeuticsCompletedSevere Postpartum DepressionUnited States
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Women's College HospitalCanadian Institutes of Health Research (CIHR); Michael Garron HospitalCompletedPostpartum Depression | Postpartum Anxiety | Postpartum Blues | Postpartum Mood DisorderCanada
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University of RochesterMae Stone Goode FoundationCompletedPostpartum Depression | Postpartum AnxietyUnited States
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Clinical Trials on duloxetine
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