Back to results

Escitalopram in the Treatment of Postpartum Depression

Primary Purpose

Postpartum Depression

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

escitalopram

About this trial

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

Eligibility Criteria

19 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.)

Sites / Locations

Reproductive Mental Health Program, BC Women's Hospital

Outcomes

Primary Outcome Measures

The primary efficacy assessment will be total score on the Montgomery-Asberg Depression Rating Scale (MADRS).

Secondary Outcome Measures

The Secondary efficacy assessment will be total score on the short form of the Quality of Life Enjoyment and Satisfaction Questionnaire.

Full Information

NCT ID

NCT01527474

First Posted

February 3, 2012

Last Updated

February 9, 2012

Sponsor

BC Women's Hospital & Health Centre

1. Study Identification

Unique Protocol Identification Number

NCT01527474

Brief Title

Escitalopram in the Treatment of Postpartum Depression

Official Title

An Open-label Study of Escitalopram in the Treatment of Postpartum Depression

Study Type

Interventional

2. Study Status

Record Verification Date

February 2012

Overall Recruitment Status

Completed

Study Start Date

April 2008 (undefined)

Primary Completion Date

May 2009 (Actual)

Study Completion Date

May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

BC Women's Hospital & Health Centre

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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. 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: i) Escitalopram will be effective in the treatment of Postpartum Depression and ii) Escitalopram will be effective in increasing the quality of life of participants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postpartum Depression

Keywords

postpartum, postpartum depression, PPD, escitalopram

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

escitalopram

Intervention Description

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.

Primary Outcome Measure Information:

Title

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.

Secondary Outcome Measure Information:

Title

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.

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shaila Misri, MD

Organizational Affiliation

University of British Columbia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Reproductive Mental Health Program, BC Women's Hospital

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6H 3N1

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

Escitalopram in the Treatment of Postpartum Depression

We'll reach out to this number within 24 hrs