Duloxetine for the Treatment of Postpartum Depression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2013-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Prophylactic Use of Postpartum Sertraline to Prevent Postpartum Depression

NCT02235064

Depression, Postpartum

TERMINATED NA

Sertraline for the Prevention of Recurrent Postpartum Depression

NCT00276900

Depression

COMPLETED PHASE3

Interpersonal Therapy-Based Treatment to Prevent Postpartum Depression in Adolescent Mothers

NCT00436150

Depression

COMPLETED NA

Functional Outcome in Postpartum Depression in Women Treated With Desvenlafaxine

NCT01527786

Depression

COMPLETED PHASE3

Using a Preparation and Education Intervention to Reduce Postpartum Depression Among New Mothers (The MADE IT 2 Study)

NCT00951717

Depression, Postpartum Depression

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Study was terminated because of poor enrollment

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postpartum Depression Major Depressive Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Duloxetine

type of experimental agent

Group Type EXPERIMENTAL

duloxetine

Intervention Type DRUG

Total treatment period is 12 weeks

30mg po qd times 1 week

60mg po qd times 11 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

duloxetine

Total treatment period is 12 weeks

30mg po qd times 1 week

60mg po qd times 11 weeks

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Cymbalta

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No