Lexapro in the Treatment of Patients With Postpartum Depression
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00277108|
Recruitment Status : Completed
First Posted : January 13, 2006
Last Update Posted : November 6, 2008
|Condition or disease||Intervention/treatment||Phase|
|Postpartum Depression||Drug: Escitalopram (Lexapro)||Not Applicable|
Primary objectives: Remission of Major Depression: To determine the efficacy of a flexibly titrated dose of Escitalopram (10mg to 20 mg) in the treatment of women with postpartum depression. The primary outcome measure will be remission of major depression, defined as a score of 12 or less on the Montgomery-Asberg Depression Scale. A score of 7 or less on the Hamilton Depression Scale (21 item) will be used as a secondary measure of remission. The null hypothesis is that flexibly dosed Escitalopram does not lead to remission of major depression based on total MADRS scores after 8 weeks of treatment.
- To determine if treatment with Escitalopram is effective in achieving significant reduction in symptoms of postpartum depression as measured on several instruments: HAM-D 21, CGI, Beck Depression Inventory, Edinburgh Postnatal Depression Scale. Specifically, a response will be defined as a reduction of the total scores of 50% or more from baseline on the MADRS or HAM-D 21.
- To determine the tolerability, safety and some dosing considerations for Escitalopram in this special subpopulation of depressed patients. Adverse events data (clinical and laboratory), compliance and early termination will be used as outcome measures.
- To determine in a post-hoc analysis if pre-study anxiety levels as measured with HAM-A correlate with primary and secondary outcomes.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open Label Variable Dose Escitalopram (Lexapro) in the Treatment of Patients With Postpartum Major Depression: A Pilot Study|
|Study Start Date :||February 2004|
|Actual Primary Completion Date :||April 2007|
|Actual Study Completion Date :||April 2007|
- The primary outcome measure will be remission of major depression, defined as a score of 12 or less on the Montgomery-Asberg Depression Scale.
- A score of 7 or less on the Hamilton Depression Scale (21 item) will be used as a secondary measure of remission.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00277108
|United States, New York|
|University of Rochester|
|Rochester, New York, United States, 14642|
|Principal Investigator:||Linda H Chaudron, MD, MS||University of Rochester|