Reproductive Mental Health Program, BC Women's Hospital
Vancouver, British Columbia, V6H 3N1, Canada
NCT Number: NCT01527474
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.
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Notify Me19 year–40 year
Female
Interventional
Not applicable
Vancouver, British Columbia, V6H 3N1, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
participants will be initiated at a dose of 10mg/day which will be adjusted by the study clinician based on the presences of depressive symptoms and side effects up to a maximum of 20mg/day.
Time frame: The primary endpoint will be the change from baseline on MADRS total score after 8-weeks of treatment.
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.
BC Women's Hospital & Health Centre
Other
An Open-label Study of Escitalopram in the Treatment of Postpartum Depression
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