Postpartum DepressionNCT00277108
Lexapro in the Treatment of Patients With Postpartum Depression
A study testing Escitalopram (Lexapro) in people with Postpartum Depression, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this study is to determine if Escitalopram (Lexapro) is effective in the treatment of postpartum depression. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Depression
- What is being tested?
- Escitalopram (Lexapro)
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to Apr 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- -
Who cannot join
- 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.
Show all 13Show fewer
- 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.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Label Variable Dose Escitalopram (Lexapro) in the Treatment of Patients With Postpartum Major Depression: A Pilot Study
The purpose of this study is to determine if Escitalopram (Lexapro) is effective in the treatment of postpartum depression.
Read the 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.
- Conditions
- Postpartum Depression
- Being tested
- Escitalopram (Lexapro)
- Keywords
- postpartum depression, postnatal depression, PPD
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Escitalopram (Lexapro)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (1)
A score of 7 or less on the Hamilton Depression Scale (21 item) will be used as a secondary measure of remission.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2006 (estimated)
- Study startFeb 2004
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Forest Laboratories
- Investigators
- Linda H Chaudron, MD, MS, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00277108
- Sponsor's protocol ID
- LXP-MD80
- Status last verified
- Nov 2008
- First submitted
- 12 Jan 2006
- Last updated
- 6 Nov 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Variable Dose Escitalopram (Lexapro) in the Treatment of Patients With Postpartum Major Depression: A Pilot Study
- ClinicalTrials.gov ID
- NCT00277108
- Acronym / sponsor ID
- LXP-MD80
- Conditions
- Postpartum Depression
- Keywords
- postpartum depression, postnatal depression, PPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Forest Laboratories
- Study start
- Feb 2004
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 13 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Escitalopram (Lexapro) | Drug | – |
Primary outcome
The primary outcome measure will be remission of major depression, defined as a score of 12 or less on the Montgomery-Asberg Depression Scale.
1 secondary outcome
A score of 7 or less on the Hamilton Depression Scale (21 item) will be used as a secondary measure of remission.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda H Chaudron, MD, MS principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Escitalopram (Lexapro) in people with Postpartum Depression, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measure will be remission of major depression, defined as a score of 12 or less on the Montgomery-Asberg Depression Scale.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2008.