Postpartum DepressionDuloxPPDNCT00617045
Duloxetine for the Treatment of Postpartum Depression
A study testing duloxetine in people with Postpartum Depression and Major Depressive Disorder, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Depression, Major Depressive Disorder
- What is being tested?
- duloxetine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- have current or lifetime psychosis
- an unstable medical condition
- hypertension
- narrow-angle glaucoma
- liver disease
- seizure disorders
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Perinatal & Postpartum Research Program 142 Temple ST Suite 301
New Haven, Connecticut, 06510
About this study
Official title: 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.
Read the detailed description
Study was terminated because of poor enrollment
- Conditions
- Postpartum Depression, Major Depressive Disorder
- Being tested
- duloxetine
- Keywords
- Post Partum Depression
- Medical subject headings
- Depression, Postpartum, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
duloxetineDrug
Also called Cymbalta
Total treatment period is 12 weeks
30mg po qd times 1 week
60mg po qd times 11 weeks
| Study group | Role | What they receive |
|---|---|---|
| Duloxetine | Experimental | type of experimental agent Receives: Drug: duloxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depression severity compared to baseline scores on the IDS-C between the two subject groups.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2008 (estimated)
- Study startJul 2007
- Primary completionDec 2012
- Study completionMay 2013
Why it stopped: poor patient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kimberly Yonkers, Yale University
- Investigators
- Kimberly A Yonkers, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00617045
- Sponsor's protocol ID
- HIC0609001827-Lilly-Duloxetine
- Other IDs
- F1J-US-X043
- Acronym
- DuloxPPD
- Status last verified
- Jun 2016
- First submitted
- 4 Feb 2008
- Last updated
- 17 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duloxetine in the Treatment of Postpartum-onset and Non-Postpartum Onset Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT00617045
- Acronym / sponsor ID
- DuloxPPD / HIC0609001827-Lilly-Duloxetine
- Conditions
- Postpartum Depression, Major Depressive Disorder
- Keywords
- Post Partum Depression
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: poor patient recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Dec 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 15 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study was terminated because of poor enrollment
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Duloxetine | Experimental | Drug: duloxetinetype of experimental agent |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (20 listed)
- have current or lifetime psychosis
- an unstable medical condition
- hypertension
- narrow-angle glaucoma
- liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| duloxetineAlso: CymbaltaTotal treatment period is 12 weeks 30mg po qd times 1 week 60mg po qd times 11 weeks | Drug | Duloxetine |
Primary outcome
Change in depression severity compared to baseline scores on the IDS-C between the two subject groups.
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimberly A Yonkers, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing duloxetine in people with Postpartum Depression and Major Depressive Disorder, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depression severity compared to baseline scores on the IDS-C between the two subject groups. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2016; AzTrials last refreshed its copy on 7 Nov 2026.