Escitalopram in the Treatment of Postpartum Depression
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:
- to investigate the efficacy of escitalopram in the treatment of PPD.
- to assess the effects of escitalopram on patients quality of life.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-label Study of Escitalopram in the Treatment of Postpartum Depression|
- The primary efficacy assessment will be total score on the Montgomery-Asberg Depression Rating Scale (MADRS). [ Time Frame: The primary endpoint will be the change from baseline on MADRS total score after 8-weeks of treatment. ] [ Designated as safety issue: No ]
- The Secondary efficacy assessment will be total score on the short form of the Quality of Life Enjoyment and Satisfaction Questionnaire. [ Time Frame: The secondary endpoint will be change from baseline on the Quality of Life Enjoyment and Satisfaction Questionnaire total score after 8-weeks of treatment. ] [ Designated as safety issue: No ]
|Study Start Date:||April 2008|
|Study Completion Date:||May 2009|
|Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01527474
|Canada, British Columbia|
|Reproductive Mental Health Program, BC Women's Hospital|
|Vancouver, British Columbia, Canada, V6H 3N1|
|Principal Investigator:||Shaila Misri, MD||University of British Columbia|