Postpartum DepressionNCT01527474
Escitalopram in the Treatment of Postpartum Depression
A study testing escitalopram in people with Postpartum Depression, run by BC Women's Hospital & Health Centre at 1 site in Canada.
Trial summary
This will be an 8-week, open-label trial evaluating the efficacy of escitalopram as monotherapy in the treatment of patients with postpartum depression (PPD). The acute phase of the study will consist of an 8 week treatment phase. Read more about this study
- Who is it for?
- Ages 19 to 40 years, women only
- Conditions the study is for
- Postpartum Depression
- What is being tested?
- escitalopram
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2008to May 2009
- 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 19 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- female between the ages of 19 to 40 years of age
- given birth in the last 6 months
- not currently breastfeeding
- meet criteria for Major Depressive Disorder as per the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV TR)
- Montgomery-Asberg Depression Rating Scale (MADRS) score greater than or equal to 25 at enrolment
- able to read and write English
- sign written informed consent to participate in the study.
Who cannot join
- have a significant risk of suicide according to the investigator's opinion or presents a score of 5 or greater on item 10 (suicidal thoughts) of of the MADRS
- meets DSM-IV-TR criteria for past or current manic or hypomanic episode, past or current psychotic symptoms or disorder, and/or has a history of drug or alcohol abuse/dependence within the last 6 months
- uses the following disallowed recent or concomitant medication within the specified time periods - any antidepressant or any drug used for augmentation of antidepressant action within the last 2 weeks (5 weeks for fluoxetine) prior to baseline, any benzodiazepines or other anxiolytics within the last week prior to baseline, any non-benzodiazepine hypnotics within the last week prior to baseline, oral antipsychotics within 2 weeks or depot antipsychotics within 6 months prior to baseline, serotonergic medicinal products (for example triptans, tryptophan, tramadol) within the last week prior to baseline, psychoactive herbal remedies (for example St. Johns Wort, kava kava, valerian, gingko biloba) within the last 2 weeks prior to baseline, any other drug with potential psychotropic effects within the last 2 weeks prior to baseline, any anticonvulsant drug within the last 2 weeks prior to baseline, or any investigational product within 3 months prior to baseline
- is currently receiving formal cognitive or behavioural therapy, systematic psychotherapy, or plans to initiate such therapy during the study
- current depressive symptoms of the patient are considered by the investigator to have been resistant to two well-conducted antidepressant treatments of at least 6 weeks duration
- has a serious illness or serious sequelae thereof, including liver or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological (including epilepsy), infectious, neoplastic, or metabolic disturbance (if there is a history of such disease but the condition has been stable for at least one year and is judged by the investigator not to render inclusion unsafe and not to interfere with the patient's participation in the study, the patient may be included.)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Reproductive Mental Health Program, BC Women's Hospital
Vancouver, British Columbia, V6H 3N1
About this study
Official title: An Open-label Study of Escitalopram in the Treatment of Postpartum Depression
This will be an 8-week, open-label trial evaluating the efficacy of escitalopram as monotherapy in the treatment of patients with postpartum depression (PPD). The acute phase of the study will consist of an 8 week treatment phase. Treatment of eligible participants will be initiated at a dose of 10mg/day which will be adjusted by the study clinician based on the presence of depressive symptoms and side effects up to a maximum of 20mg/day.
Study objectives are:
- to investigate the efficacy of escitalopram in the treatment of PPD.
- to assess the effects of escitalopram on patients quality of life.
Read the detailed description
Major Depression Postpartum Onset (PPD) is a chronic relapsing illness which affects not only maternal mood but also the baby and family. Therefore, it is critical to aim for timely intervention once the diagnosis is made. Studies have shown that antidepressant medications are effective in treatment for moderate to severe PPD. Common reasons for noncompliance and discontinuation of antidepressant medications in the postpartum period are the side effects associated with different antidepressants. To choose an antidepressant medication with proven efficacy and a tolerable side effect profile is key in order to maximize adherence to pharmacotherapy.
A number of studies have been published that highlight the efficacy of escitalopram in the treatment of Major Depressive Disorder (MDD). However, there has been no research to date investigating the effectiveness of escitalopram in the treatment of PPD.
Based upon the preliminary clinical observations in our tertiary care program (Provincial Reproductive Mental Health Program) where a postpartum depressed population is frequently treated with antidepressant medications, compliance with escitalopram has been impressive. Therefore, we propose to conduct an open-label study with escitalopram in postpartum depressed, non-lactating mothers to confirm our clinical observation.
Hypotheses:
- Escitalopram will be effective in the treatment of Postpartum Depression and ii) Escitalopram will be effective in increasing the quality of life of participants.
- Conditions
- Postpartum Depression
- Being tested
- escitalopram
- Keywords
- postpartum, postpartum depression, PPD, escitalopram
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
escitalopramDrug
participants will be initiated at a dose of 10mg/day which will be adjusted by the study clinician based on the presences of depressive symptoms and side effects up to a maximum of 20mg/day.
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy assessment will be total score on the Montgomery-Asberg Depression Rating Scale (MADRS).
Measured: The primary endpoint will be the change from baseline on MADRS total score after 8-weeks of treatment.
Secondary outcomes (1)
The Secondary efficacy assessment will be total score on the short form of the Quality of Life Enjoyment and Satisfaction Questionnaire.
Measured: The secondary endpoint will be change from baseline on the Quality of Life Enjoyment and Satisfaction Questionnaire total score after 8-weeks of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2012 (estimated)
- Study startApr 2008
- Primary completionMay 2009
- Study completionMay 2009
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- BC Women's Hospital & Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Shaila Misri, BC Women's Hospital & Health Centre
- Investigators
- Shaila Misri, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01527474
- Sponsor's protocol ID
- SM1562007
- Status last verified
- Feb 2012
- First submitted
- 3 Feb 2012
- Last updated
- 10 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study of Escitalopram in the Treatment of Postpartum Depression
- ClinicalTrials.gov ID
- NCT01527474
- Acronym / sponsor ID
- SM1562007
- Conditions
- Postpartum Depression
- Keywords
- postpartum, postpartum depression, PPD, escitalopram
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- BC Women's Hospital & Health CentreUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 7 Feb 2012 (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.
This will be an 8-week, open-label trial evaluating the efficacy of escitalopram as monotherapy in the treatment of patients with postpartum depression (PPD). The acute phase of the study will consist of an 8 week treatment phase. Treatment of eligible participants will be initiated at a dose of 10mg/day which will be adjusted by the study clinician based on the presence of depressive symptoms and side effects up to a maximum of 20mg/day.
Study objectives are:
- to investigate the efficacy of escitalopram in the treatment of PPD.
- to assess the effects of escitalopram on patients quality of life.
Detailed description
Major Depression Postpartum Onset (PPD) is a chronic relapsing illness which affects not only maternal mood but also the baby and family. Therefore, it is critical to aim for timely intervention once the diagnosis is made. Studies have shown that antidepressant medications are effective in treatment for moderate to severe PPD. Common reasons for noncompliance and discontinuation of antidepressant medications in the postpartum period are the side effects associated with different antidepressants. To choose an antidepressant medication with proven efficacy and a tolerable side effect profile is key in order to maximize adherence to pharmacotherapy.
A number of studies have been published that highlight the efficacy of escitalopram in the treatment of Major Depressive Disorder (MDD). However, there has been no research to date investigating the effectiveness of escitalopram in the treatment of PPD.
Based upon the preliminary clinical observations in our tertiary care program (Provincial Reproductive Mental Health Program) where a postpartum depressed population is frequently treated with antidepressant medications, compliance with escitalopram has been impressive. Therefore, we propose to conduct an open-label study with escitalopram in postpartum depressed, non-lactating mothers to confirm our clinical observation.
Hypotheses:
- Escitalopram will be effective in the treatment of Postpartum Depression and ii) Escitalopram will be effective in increasing the quality of life of participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- female between the ages of 19 to 40 years of age
- given birth in the last 6 months
- not currently breastfeeding
- meet criteria for Major Depressive Disorder as per the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV TR)
- Montgomery-Asberg Depression Rating Scale (MADRS) score greater than or equal to 25 at enrolment
Key exclusion criteria (6 listed)
- have a significant risk of suicide according to the investigator's opinion or presents a score of 5 or greater on item 10 (suicidal thoughts) of of the MADRS
- meets DSM-IV-TR criteria for past or current manic or hypomanic episode, past or current psychotic symptoms or disorder, and/or has a history of drug or alcohol abuse/dependence within the last 6 months
- uses the following disallowed recent or concomitant medication within the specified time periods - any antidepressant or any drug used for augmentation of antidepressant action within the last 2 weeks (5 weeks for fluoxetine) prior to baseline, any benzodiazepines or other anxiolytics within the last week prior to baseline, any non-benzodiazepine hypnotics within the last week prior to baseline, oral antipsychotics within 2 weeks or depot antipsychotics within 6 months prior to baseline, serotonergic medicinal products (for example triptans, tryptophan, tramadol) within the last week prior to baseline, psychoactive herbal remedies (for example St. Johns Wort, kava kava, valerian, gingko biloba) within the last 2 weeks prior to baseline, any other drug with potential psychotropic effects within the last 2 weeks prior to baseline, any anticonvulsant drug within the last 2 weeks prior to baseline, or any investigational product within 3 months prior to baseline
- is currently receiving formal cognitive or behavioural therapy, systematic psychotherapy, or plans to initiate such therapy during the study
- current depressive symptoms of the patient are considered by the investigator to have been resistant to two well-conducted antidepressant treatments of at least 6 weeks duration
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 |
|---|---|---|
| escitalopramparticipants will be initiated at a dose of 10mg/day which will be adjusted by the study clinician based on the presences of depressive symptoms and side effects up to a maximum of 20mg/day. | Drug | – |
Primary outcome
The primary efficacy assessment will be total score on the Montgomery-Asberg Depression Rating Scale (MADRS).
Time frame: The primary endpoint will be the change from baseline on MADRS total score after 8-weeks of treatment.
1 secondary outcome
The Secondary efficacy assessment will be total score on the short form of the Quality of Life Enjoyment and Satisfaction Questionnaire.
Time frame: The secondary endpoint will be change from baseline on the Quality of Life Enjoyment and Satisfaction Questionnaire total score after 8-weeks of treatment.
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 10 Feb 2012.
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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.
Shaila Misri, MD principal investigator
University of British Columbia
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 in people with Postpartum Depression, run by BC Women's Hospital & Health Centre at 1 site in Canada.
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 6 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 10 Feb 2012. 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 Canada. 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 efficacy assessment will be total score on the Montgomery-Asberg Depression Rating Scale (MADRS). (time frame: The primary endpoint will be the change from baseline on MADRS total score after 8-weeks of treatment.). 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 10 Feb 2012; AzTrials last refreshed its copy on 8 Nov 2026.