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Trial record 29 of 468 for:    ESCITALOPRAM AND Cholinergic

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

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: NCT00833469
Recruitment Status : Completed
First Posted : February 2, 2009
Results First Posted : August 6, 2014
Last Update Posted : August 6, 2014
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Marlene P. Freeman, MD, Massachusetts General Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Postpartum Depression
Intervention Drug: Escitalopram
Enrollment 7
Recruitment Details  
Pre-assignment Details Seven subjects were enrolled in this study. Prior to receiving treatment, two subjects were found to be ineligible per protocol eligibility requirements.
Arm/Group Title Escitalopram
Hide Arm/Group Description Flexible dose escitalopram 10mg once daily by mouth (maximum of 20mg, minimum of 5mg, per the investigator's discretion).
Period Title: Overall Study
Started 5
Completed 3
Not Completed 2
Reason Not Completed
Withdrawal by Subject             1
Lost to Follow-up             1
Arm/Group Title Escitalopram
Hide Arm/Group Description

Flexible dose escitalopram 10mg

Escitalopram: Once daily by mouth

Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
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.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
<=18 years
0
   0.0%
Between 18 and 65 years
4
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
4
 100.0%
Male
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
3
  75.0%
More than one race
0
   0.0%
Unknown or Not Reported
1
  25.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Hispanic or Latino
1
  25.0%
Not Hispanic or Latino
3
  75.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants
4
1.Primary Outcome
Title Change in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS)
Hide Description The Montgomery-Åsberg Depression Rating Scale is a widely used 10-item clinician-rated scale that describes the severity of depressive symptoms (range 0-60, higher score indicates greater symptom burden).
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Of 7 subjects consented, 5 were eligible after V1. Before V2, 1 subject dropped and 1 was LTF. Three subjects completed the study.
Arm/Group Title Escitalopram
Hide Arm/Group Description:
Flexible dose escitalopram 10mg once daily by mouth (maximum of 20mg, minimum of 5mg, per the investigator's discretion).
Overall Number of Participants Analyzed 3
Mean (Standard Deviation)
Unit of Measure: units on a scale
-21.33  (11.24)
2.Secondary Outcome
Title Change in Edinburgh Postnatal Depression Scale (EPDS)
Hide Description The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report used to measure postpartum depression (range 0-30, higher score indicates greater symptom burden). A score of >9 is indicative of perinatal major depression.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Of 7 subjects consented, 5 were eligible after V1. Before V2, 1 subject dropped and 1 was LTF. Three subjects completed the study.
Arm/Group Title Escitalopram
Hide Arm/Group Description:
Flexible dose escitalopram 10mg once daily by mouth (maximum of 20mg, minimum of 5mg, per the investigator's discretion).
Overall Number of Participants Analyzed 3
Mean (Standard Deviation)
Unit of Measure: units on a scale
-19.33  (2.52)
3.Secondary Outcome
Title Change in Beck Anxiety Inventory (BAI)
Hide Description Beck Anxiety Inventory (BAI): The BAI is a 21-item self-report questionnaire measuring typical symptoms of anxiety during the past week (range 0-63, higher score indicates greater anxiety).
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Of 7 subjects consented, 5 were eligible after V1. Before V2, 1 subject dropped and 1 was LTF. Three subjects completed the study.
Arm/Group Title Escitalopram
Hide Arm/Group Description:
Flexible dose escitalopram 10mg once daily by mouth (maximum of 20mg, minimum of 5mg, per the investigator's discretion).
Overall Number of Participants Analyzed 3
Mean (Standard Deviation)
Unit of Measure: units on a scale
-15.00  (9.85)
Time Frame 32 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Escitalopram
Hide Arm/Group Description Flexible dose escitalopram 10mg once daily by mouth (maximum of 20mg, minimum of 5mg, per the investigator's discretion).
All-Cause Mortality
Escitalopram
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Escitalopram
Affected / at Risk (%)
Total   0/3 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Escitalopram
Affected / at Risk (%)
Total   3/3 (100.00%) 
Gastrointestinal disorders   
Nausea  2/3 (66.67%) 
Musculoskeletal and connective tissue disorders   
Jaw tightness  1/3 (33.33%) 
Nervous system disorders   
Decreased sleep  1/3 (33.33%) 
Reproductive system and breast disorders   
Vaginal discharge  1/3 (33.33%) 
Skin and subcutaneous tissue disorders   
Dry skin  1/3 (33.33%) 
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.
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
Layout table for Results Point of Contact information
Name/Title: Dr. Marlene Freeman, MD
Organization: Massachusetts General Hospital
Phone: 617-643-6403
EMail: mfreeman@partners.org
Layout table for additonal information
Responsible Party: Marlene P. Freeman, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00833469     History of Changes
Other Study ID Numbers: 2008-P-001509
First Submitted: January 29, 2009
First Posted: February 2, 2009
Results First Submitted: July 11, 2014
Results First Posted: August 6, 2014
Last Update Posted: August 6, 2014