Treatment of Postpartum Depression With Psychotherapy and Add-on Sertraline
Postpartum Depression
About this trial
This is an interventional treatment trial for Postpartum Depression focused on measuring severity of depression measured by MADRS and CGI
Eligibility Criteria
Inclusion Criteria:
- Women 18- 45 y.o.
- SCID-DSM-IV diagnosis of major depression, mild to moderate severity
- Understanding of Hebrew
- Willing to sign the informed consent
- Lactating women will be included after a thorough explanation of current knowledge of sertraline and lactation.
Exclusion Criteria:
- Severe major depression (MADRS > 30)
- Suicidal ideation (MADRS item 10 score of > 5)
- Psychotic symptoms or aggressive thoughts toward the baby.
- Current treatment with antidepressant medication
- Physical illness explaining depressive symptoms (e.g. hypothyroidism, neurological disease, severe anemia, renal failure etc.)
- Alcoholism or drug abuse and dependence
- Bipolar Disorder
- Past severe side effects to SSRIs
Sites / Locations
- Tel Aviv Sourasky Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
sertraline, psychotherapy
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.
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.