Escitalopram in the Treatment of Postpartum Depression

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Shaila Misri, BC Women's Hospital & Health Centre
ClinicalTrials.gov Identifier:
NCT01527474
First received: February 3, 2012
Last updated: February 9, 2012
Last verified: February 2012

February 3, 2012
February 9, 2012
April 2008
May 2009   (final data collection date for 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. ] [ Designated as safety issue: No ]
The primary efficacy assessment will be total score on the MADRS. [ Time Frame: The primary endpoint will be the change from baseline on MADRS total score after 8-weeks of treatment. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01527474 on ClinicalTrials.gov Archive Site
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. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Escitalopram in the Treatment of Postpartum Depression
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:

  1. to investigate the efficacy of escitalopram in the treatment of PPD.
  2. to assess the effects of escitalopram on patients quality of life.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Postpartum Depression
Drug: escitalopram
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
May 2009
May 2009   (final data collection date for primary outcome measure)

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.)
Female
19 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01527474
SM1562007
No
Dr. Shaila Misri, BC Women's Hospital & Health Centre
BC Women's Hospital & Health Centre
Not Provided
Principal Investigator: Shaila Misri, MD University of British Columbia
BC Women's Hospital & Health Centre
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP