Duloxetine for the Treatment of Postpartum Depression



Status:Withdrawn
Conditions:Depression, Major Depression Disorder (MDD), Women's Studies
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases, Reproductive
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:July 2007
End Date:May 2013

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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.


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
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