Please select the eligibility criteria that correspond to the clinical trial below.
Title: Treatment of Postpartum Depression With Psychotherapy and Add-on Sertraline
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 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.


Options:
A: Inclusion Criteria:

* Primary DSM-IV diagnosis of major depressive disorder by clinical interview
* Score of greater than 12 on HAM-D
* Delivery of an infant within the 12 months prior to study entry
* Able to speak and read English sufficiently to complete the study procedures
* Willing to use effective birth control methods throughout the study

Exclusion Criteria:

* Woman whose infant has died prior to study entry
* Current or past diagnosis of bipolar disorder, schizophrenia or other psychotic disorder;
* Diagnosis of alcohol or drug abuse or dependence (except nicotine) or anorexia in the past year;
* Psychotic symptoms;
* Acute suicidal or homicidal risks;
* Women who have been on an antidepressant for more than 14 days prior to consent, (if less than 14 days and willing to taper off, will be eligible to continue once tapered off);
* Women on daily anxiolytic medication (i.e. benzodiazepine, buspirone) or daily psychoactive herbal preparation (St. John's Wort or Fish Oil) (if willing to discontinue these substances may be eligible once they have been tapered off);
* Medications taken PRN over the listed dose and frequency (women will still be eligible if they take: Lunesta/Eszopiclone 3 mg or less, up to 3 nights a week, Ambien/Zolpidem 5mg or less, Ambien CR 6.25 mg or less, up to 3 nights a week, Lorazepam or equivalent benzodiazepine dose: 0.5 mg up to 3 nights a week, Sonata/Zaleplon: 5 mg or less, up to 3 nights a week, Rozerem/Ramelteon: 8 mg or less, up to 3 nights a week);
* If they take antidepressants PRN for insomnia (eg: Desyrel/Trazodone, Elavil/Amitriptyline, Remeron/Mirtazapine;
* Ongoing concurrent psychotherapeutic treatment or psychotherapeutic treatment within the last month;
* Psychiatric symptoms requiring specialized psychiatric treatment;
* Significant medical disorder that would make sertraline treatment contra-indicated,
* Previous trial of IPT therapy with a certified IPT therapist or an adequate trial of sertraline (i.e. at least 8 weeks of at least 100 mg daily of sertraline).
B: Inclusion Criteria:

* 4-6 weeks postpartum
* English-speaking
* Score of at least 10 on the Edinburgh Postnatal Depression Scale

Exclusion Criteria:

* DSM-IV diagnosis of bipolar disorder or psychotic episode
* Active substance abuse within 6 months prior to study entry
* Has not received obstetrical care
* History of a suicide attempt within 6 months of study entry
C: Inclusion Criteria:

* Mothers meeting criteria for current DSM-IV major depression were eligible.

Exclusion Criteria:

* who had received any form of treatment for their depression during their current postnatal period,
* those who were pregnant,
* with psychotic symptoms,
* serious suicidal risk,
* history of mania,
* alcohol or drug abuse
D: 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

Answer: D