Ignite Creation Date:
2024-05-05 @ 10:04 PM
Last Modification Date:
2024-10-26 @ 10:13 AM
Study NCT ID:
NCT01028482
Status:
COMPLETED
Last Update Posted:
2011-05-10
First Post:
2009-06-03
Brief Title:
Treatment of Postpartum Depression With Psychotherapy and Add-on Sertraline
Sponsor:
Tel-Aviv Sourasky Medical Center
Organization:
Tel-Aviv Sourasky Medical Center
Study Overview
Official Title:
Treatment of Postpartum Depression With Psychotherapy and Add-on Sertraline
Status:
COMPLETED
Status Verified Date:
2011-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Introduction
Postpartum depression PPD occurs in large numbers of women between 10 - 20 and substantially affects both their own well-being and their offsprings mental and emotional development Whereas PPD is a form of major depression its etiology is probably related to a combination of biological hereditary hormonal etc and psychological factors In practice most women suffering from PPD do not seek treatment or are treated with psychotherapy alone due to concerns regarding pharmacotherapy This is despite the obvious importance of reaching a rapid remission in these women In fact data regarding the treatment of PPD with antidepressants is surprisingly sparse and is limited to only one blinded and placebo-controlled study with fluoxetine and a number of studies without a placebo arm The reason for the paucity of double-blinded placebo-controlled studies is probably due to 3 main limiting factors Firstly the reluctance of women to admit to and seek professional help due to depression Secondly the difficulty to administer antidepressant medication to lactating women and Thirdly the ethical difficulties in designing a study with a real placebo group
In contrast to the very limited number of drug studies in this population there are a number of studies that have shown the efficacy of psychotherapy in the treatment of PPD Positive studies have been published using different types of psychotherapy including cognitive dynamic and interpersonal psychotherapy
The investigators propose to study the efficacy of psychotherapeutic treatment in women suffering from PPD with add-on sertraline in a randomized double-blind placebo-controlled design To overcome the difficulties described above in studying antidepressants in the postpartum period the investigators propose to include active brief dynamic psychotherapy for all women Furthermore the investigators will selectively allow inclusion of women who only suffer from either mild or moderate major PPD not severe suicidal
Hypothesis
The investigators hypothesize that women with PPD randomized to the arm receiving psychotherapy active sertraline will show a greater response rate than the psychotherapy placebo group Furthermore the investigators hypothesize that the difference in response between the 2 groups will demonstrate a significant early response in the active sertraline group
Postpartum depression PPD occurs in large numbers of women between 10 - 20 and substantially affects both their own well-being and their offsprings mental and emotional development Whereas PPD is a form of major depression its etiology is probably related to a combination of biological hereditary hormonal etc and psychological factors In practice most women suffering from PPD do not seek treatment or are treated with psychotherapy alone due to concerns regarding pharmacotherapy This is despite the obvious importance of reaching a rapid remission in these women In fact data regarding the treatment of PPD with antidepressants is surprisingly sparse and is limited to only one blinded and placebo-controlled study with fluoxetine and a number of studies without a placebo arm The reason for the paucity of double-blinded placebo-controlled studies is probably due to 3 main limiting factors Firstly the reluctance of women to admit to and seek professional help due to depression Secondly the difficulty to administer antidepressant medication to lactating women and Thirdly the ethical difficulties in designing a study with a real placebo group
In contrast to the very limited number of drug studies in this population there are a number of studies that have shown the efficacy of psychotherapy in the treatment of PPD Positive studies have been published using different types of psychotherapy including cognitive dynamic and interpersonal psychotherapy
The investigators propose to study the efficacy of psychotherapeutic treatment in women suffering from PPD with add-on sertraline in a randomized double-blind placebo-controlled design To overcome the difficulties described above in studying antidepressants in the postpartum period the investigators propose to include active brief dynamic psychotherapy for all women Furthermore the investigators will selectively allow inclusion of women who only suffer from either mild or moderate major PPD not severe suicidal
Hypothesis
The investigators hypothesize that women with PPD randomized to the arm receiving psychotherapy active sertraline will show a greater response rate than the psychotherapy placebo group Furthermore the investigators hypothesize that the difference in response between the 2 groups will demonstrate a significant early response in the active sertraline group
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None