Escitalopram (Lexapro) for the Treatment of Postpartum Depression (LexaproPPD)

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Marlene P. Freeman, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00833469
First received: January 29, 2009
Last updated: August 5, 2014
Last verified: August 2014
Results First Received: July 11, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Postpartum Depression
Intervention: Drug: Escitalopram

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Seven subjects were enrolled in this study. Prior to receiving treatment, two subjects were found to be ineligible per protocol eligibility requirements.

Reporting Groups
  Description
Escitalopram Flexible dose escitalopram 10mg once daily by mouth (maximum of 20mg, minimum of 5mg, per the investigator's discretion).

Participant Flow:   Overall Study
    Escitalopram  
STARTED     5  
COMPLETED     3  
NOT COMPLETED     2  
Withdrawal by Subject                 1  
Lost to Follow-up                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Of the 7 subjects consented, 5 were eligible to initiate study intervention. Out of these 5, 1 subject dropped prior to V1 and no baseline information is available for her.

Reporting Groups
  Description
Escitalopram

Flexible dose escitalopram 10mg

Escitalopram: Once daily by mouth


Baseline Measures
    Escitalopram  
Number of Participants  
[units: participants]
  4  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     4  
>=65 years     0  
Gender  
[units: participants]
 
Female     4  
Male     0  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     0  
White     3  
More than one race     0  
Unknown or Not Reported     1  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     1  
Not Hispanic or Latino     3  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     4  



  Outcome Measures
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1.  Primary:   Change in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS)   [ Time Frame: 8 weeks ]

2.  Secondary:   Change in Edinburgh Postnatal Depression Scale (EPDS)   [ Time Frame: 8 weeks ]

3.  Secondary:   Change in Beck Anxiety Inventory (BAI)   [ Time Frame: 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
We recruited only 7 patients out of a projected 20. Patients were not referred because they were breastfeeding or preferred to receive treatment from their primary care doctor. We also suspect that many women with PPD do not seek treatment at all.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Marlene Freeman, MD
Organization: Massachusetts General Hospital
phone: 617-643-6403
e-mail: mfreeman@partners.org


No publications provided


Responsible Party: Marlene P. Freeman, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00833469     History of Changes
Other Study ID Numbers: 2008-P-001509
Study First Received: January 29, 2009
Results First Received: July 11, 2014
Last Updated: August 5, 2014
Health Authority: United States: Institutional Review Board