Escitalopram in the Treatment of Postpartum Depression

Status Completed

Clinical Trial Summary

This will be an 8-week, open-label trial evaluating the efficacy of escitalopram as monotherapy in the treatment of patients with postpartum depression (PPD). The acute phase of the study will consist of an 8 week treatment phase. Treatment of eligible participants will be initiated at a dose of 10mg/day which will be adjusted by the study clinician based on the presence of depressive symptoms and side effects up to a maximum of 20mg/day.

Study objectives are:

1. to investigate the efficacy of escitalopram in the treatment of PPD.

2. to assess the effects of escitalopram on patients quality of life.

Clinical Trial Description

Major Depression Postpartum Onset (PPD) is a chronic relapsing illness which affects not only maternal mood but also the baby and family. Therefore, it is critical to aim for timely intervention once the diagnosis is made. Studies have shown that antidepressant medications are effective in treatment for moderate to severe PPD. Common reasons for noncompliance and discontinuation of antidepressant medications in the postpartum period are the side effects associated with different antidepressants. To choose an antidepressant medication with proven efficacy and a tolerable side effect profile is key in order to maximize adherence to pharmacotherapy.

A number of studies have been published that highlight the efficacy of escitalopram in the treatment of Major Depressive Disorder (MDD). However, there has been no research to date investigating the effectiveness of escitalopram in the treatment of PPD.

Based upon the preliminary clinical observations in our tertiary care program (Provincial Reproductive Mental Health Program) where a postpartum depressed population is frequently treated with antidepressant medications, compliance with escitalopram has been impressive. Therefore, we propose to conduct an open-label study with escitalopram in postpartum depressed, non-lactating mothers to confirm our clinical observation.

Hypotheses:

i) Escitalopram will be effective in the treatment of Postpartum Depression and ii) Escitalopram will be effective in increasing the quality of life of participants. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01527474
Study type	Interventional
Source	BC Women's Hospital & Health Centre
Contact
Status	Completed
Phase	N/A
Start date	April 2008
Completion date	May 2009

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.