Conditions:
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.
Dates: July 2007 -
Study Status: Recruiting
Ages Eligible: 18 Years and older
Gender Eligible: Female
This trial accepts 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
Sponsor:
First Received: February 4, 2008
Last Updated: January 13, 2010
Clinicaltrials.gov ID:
NCT00617045
Study HIC # 0609001827
Conditions:
Intervention: Drug: duloxetine
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.
Dates: July 2007 -
Study Status: Recruiting
Ages Eligible: 18 Years and older
Gender Eligible: Female
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
Sponsor:
First Received: February 4, 2008
Last Updated: January 13, 2010
Clinicaltrials.gov ID:
NCT00617045
Study HIC # 0609001827
Heather Howell, MSW, LCSW
764-6764
Yonkers, Kimberly Ann
Principal Investigator
HIC # 0805003779
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