Treatment of Postpartum Depression With Psychotherapy and Add-on Sertraline

Postpartum Depression Clinical Trial

Official title:

Treatment of Postpartum Depression With Psychotherapy and Add-on Sertraline

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01028482
• Other study ID #: TASMC-09-MB-301-CTIL
• Status: Completed
• Phase: N/A
• First received: June 3, 2009
• Last updated: May 9, 2011
• Start date: March 2008
• Est. completion date: January 2011

Study information

• Verified date: May 2011
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: January 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Postpartum Depression

Intervention

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
• placebo
placebo

Other:
• psychotherapy
psychotherapy

Locations

Country	Name	City	State
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	depression		12 weeks	No