search
Back to results

Lexapro in the Treatment of Patients With Postpartum Depression

Primary Purpose

Postpartum Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Escitalopram (Lexapro)
Sponsored by
University of Rochester
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postpartum Depression focused on measuring postpartum depression, postnatal depression, PPD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Biological mothers of infants ages 2 weeks to 12 months of age Age 18 and over Must understand and speak English well enough to read and provide written informed consent, complete written questionnaires and complete the SCID. The primary Axis I diagnosis, as determined by the SCID, must meet the DSM-IV criteria for Unipolar Major Depression, Single or Recurrent, Moderate to Severe. Onset of depression must occur within pregnancy to the first 12 months following childbirth. Concurrent diagnoses of anxiety disorders including obsessive compulsive disorder, panic disorder, specific phobias, generalized anxiety disorder, and post-traumatic stress disorder will be allowed if they are not the primary diagnosis. The subject must receive a MADRS total score of > 22 at screening and at the baseline visit and a total score of >17 on the HAM-D at the baseline visit. The subject must be able to comply with instructions and be capable of participating in an 8 week study. - Exclusion Criteria: Under 18 years of age. Subjects who are breastfeeding. History of Bipolar Disorder, Schizoaffective Disorder, Schizophrenia. History of any DSM-IV Axis II diagnosis, which in the investigator's opinion, would interfere with compliance of the protocol. History of alcohol or drug abuse or dependence in the last year. Treatment with other psychotropic drugs except permissible concomitants. Current severe psychiatric symptoms requiring psychiatric hospitalization, current psychosis or suicidal, homicidal potential. History of intolerance to or hypersensitivity to Citalopram. Subjects whose depressions are known to be unresponsive to Escitalopram. Subjects who are pregnant or who intend to become pregnant during the course of the study. Subjects who have any medical or neurological disorder that in the investigators' opinion may contribute to depression. Subjects who have started psychotherapy within three months prior to baseline or who intend to start psychotherapy during the study. -

Sites / Locations

  • University of Rochester

Outcomes

Primary Outcome Measures

The primary outcome measure will be remission of major depression, defined as a score of 12 or less on the Montgomery-Asberg Depression Scale.

Secondary Outcome Measures

A score of 7 or less on the Hamilton Depression Scale (21 item) will be used as a secondary measure of remission.

Full Information

First Posted
January 12, 2006
Last Updated
November 5, 2008
Sponsor
University of Rochester
Collaborators
Forest Laboratories
search

1. Study Identification

Unique Protocol Identification Number
NCT00277108
Brief Title
Lexapro in the Treatment of Patients With Postpartum Depression
Official Title
Open Label Variable Dose Escitalopram (Lexapro) in the Treatment of Patients With Postpartum Major Depression: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Rochester
Collaborators
Forest Laboratories

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to determine if Escitalopram (Lexapro) is effective in the treatment of postpartum depression.
Detailed Description
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. Secondary objectives: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depression
Keywords
postpartum depression, postnatal depression, PPD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Escitalopram (Lexapro)
Primary Outcome Measure Information:
Title
The primary outcome measure will be remission of major depression, defined as a score of 12 or less on the Montgomery-Asberg Depression Scale.
Secondary Outcome Measure Information:
Title
A score of 7 or less on the Hamilton Depression Scale (21 item) will be used as a secondary measure of remission.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Biological mothers of infants ages 2 weeks to 12 months of age Age 18 and over Must understand and speak English well enough to read and provide written informed consent, complete written questionnaires and complete the SCID. The primary Axis I diagnosis, as determined by the SCID, must meet the DSM-IV criteria for Unipolar Major Depression, Single or Recurrent, Moderate to Severe. Onset of depression must occur within pregnancy to the first 12 months following childbirth. Concurrent diagnoses of anxiety disorders including obsessive compulsive disorder, panic disorder, specific phobias, generalized anxiety disorder, and post-traumatic stress disorder will be allowed if they are not the primary diagnosis. The subject must receive a MADRS total score of > 22 at screening and at the baseline visit and a total score of >17 on the HAM-D at the baseline visit. The subject must be able to comply with instructions and be capable of participating in an 8 week study. - Exclusion Criteria: Under 18 years of age. Subjects who are breastfeeding. History of Bipolar Disorder, Schizoaffective Disorder, Schizophrenia. History of any DSM-IV Axis II diagnosis, which in the investigator's opinion, would interfere with compliance of the protocol. History of alcohol or drug abuse or dependence in the last year. Treatment with other psychotropic drugs except permissible concomitants. Current severe psychiatric symptoms requiring psychiatric hospitalization, current psychosis or suicidal, homicidal potential. History of intolerance to or hypersensitivity to Citalopram. Subjects whose depressions are known to be unresponsive to Escitalopram. Subjects who are pregnant or who intend to become pregnant during the course of the study. Subjects who have any medical or neurological disorder that in the investigators' opinion may contribute to depression. Subjects who have started psychotherapy within three months prior to baseline or who intend to start psychotherapy during the study. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda H Chaudron, MD, MS
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Lexapro in the Treatment of Patients With Postpartum Depression

We'll reach out to this number within 24 hrs