Treatment of Postpartum Depression With Psychotherapy and Add-on Sertraline

This study has been completed.
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01028482
First received: June 3, 2009
Last updated: May 9, 2011
Last verified: May 2011
  Purpose

Introduction:

Postpartum depression (PPD) occurs in large numbers of women (between 10 - 20%) and substantially affects both their own well-being and their offspring's 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.


Condition Intervention
Postpartum Depression
Drug: Sertraline
Drug: placebo
Other: psychotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Postpartum Depression With Psychotherapy and Add-on Sertraline

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • depression [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: March 2008
Study Completion Date: January 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sertraline, psychotherapy
both study groups will receive concomitant psychotherapy treatment. There will be 2 main comparison groups: 1) an sertraline treated group and 2) a drug placebo - controlled group. While this design lacks a blinded "drug-only" condition, we will have an "open" drug-only arm that will be of considerable value. Furthermore, while a true placebo group is also lacking, and a certain response to psychotherapy is expected, we believe that the drug condition will show a definite superiority to the psychotherapy + placebo condition. The rational for including psychotherapy in the treatment protocol is the fact that this is a well-established treatment for PPD, and for ethical considerations it is unreasonable not to administer any active treatment to women suffering from PPD. It is our conviction that this is the only design, albeit its limitations, which will allow a comparison between medication-treated vs. placebo-treated PPD patients.
Drug: Sertraline

group A- sertraline 50-100 mg/day and weekly psychotherapy for 3 months

group B- weekly psychotherapy- for 3 months

group C- sertraline 50-100 mg/day-for 3 months

Other: psychotherapy
psychotherapy
Placebo Comparator: placebo, psychotherapy
both study groups will receive concomitant psychotherapy treatment. There will be 2 main comparison groups: 1) an sertraline treated group and 2) a drug placebo - controlled group. While this design lacks a blinded "drug-only" condition, we will have an "open" drug-only arm that will be of considerable value. Furthermore, while a true placebo group is also lacking, and a certain response to psychotherapy is expected, we believe that the drug condition will show a definite superiority to the psychotherapy + placebo condition. The rational for including psychotherapy in the treatment protocol is the fact that this is a well-established treatment for PPD, and for ethical considerations it is unreasonable not to administer any active treatment to women suffering from PPD. It is our conviction that this is the only design, albeit its limitations, which will allow a comparison between medication-treated vs. placebo-treated PPD patients.
Drug: placebo
placebo
Other: psychotherapy
psychotherapy

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Women 18- 45 y.o.
  2. SCID-DSM-IV diagnosis of major depression, mild to moderate severity
  3. Understanding of Hebrew
  4. Willing to sign the informed consent
  5. Lactating women will be included after a thorough explanation of current knowledge of sertraline and lactation.

Exclusion Criteria:

  1. Severe major depression (MADRS > 30)
  2. Suicidal ideation (MADRS item 10 score of > 5)
  3. Psychotic symptoms or aggressive thoughts toward the baby.
  4. Current treatment with antidepressant medication
  5. Physical illness explaining depressive symptoms (e.g. hypothyroidism, neurological disease, severe anemia, renal failure etc.)
  6. Alcoholism or drug abuse and dependence
  7. Bipolar Disorder
  8. Past severe side effects to SSRIs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01028482

Locations
Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
  More Information

No publications provided by Tel-Aviv Sourasky Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Miki Bloch MD, Tel aviv Sourasky medical center
ClinicalTrials.gov Identifier: NCT01028482     History of Changes
Other Study ID Numbers: TASMC-09-MB-301-CTIL
Study First Received: June 3, 2009
Last Updated: May 9, 2011
Health Authority: Israel: Ethics Commission

Keywords provided by Tel-Aviv Sourasky Medical Center:
severity of depression measured by MADRS and CGI

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depression, Postpartum
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications
Sertraline
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 31, 2014