Duloxetine for the Treatment of Postpartum Depression

Duloxetine in the Treatment of Postpartum-onset and Non-Postpartum Onset Major Depressive Disorder

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00617045

Acronym

DuloxPPD

Enrollment

Registered

2008-02-15

Start date

2007-07-31

Completion date

2013-05-31

Last updated

2016-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder, Postpartum Depression

Keywords

Post Partum Depression

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.

Detailed description

Study was terminated because of poor enrollment

Interventions

DRUGduloxetine

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in depression severity compared to baseline scores on the IDS-C between the two subject groups.	12 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026