Duloxetine for the Treatment of Postpartum Depression

Yale University

Overview

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 was terminated because of poor enrollment

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Postpartum Depression Major Depressive Disorder

Interventions

duloxetineDRUG

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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Perinatal & Postpartum Research Program 142 Temple ST Suite 301

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

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

Time frame: 12 weeks

Data from ClinicalTrials.gov

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