Add-On Sertraline Nixed for Moderate Postpartum Depression

Jill Stein

September 06, 2011

September 6, 2011 (Paris, France) — The antidepressant sertraline appears to provide no benefit for the management of nonsevere postpartum depression, Israeli investigators announced here at the 24th Congress of the European College of Neuropsychopharmacology (ECNP).

Their study found that sertraline was no more effective than placebo for treating mild and moderate cases of postpartum depression in women undergoing conventional psychotherapy.

Dr. Miki Bloch

"Our findings mean that sertraline added to psychotherapy in women with moderate postpartum depression offers no improvement on top of that provided by psychotherapy alone," Miki Bloch, MD, who is head of the Ambulatory Psychiatry Department at Sourasky Tel Aviv Medical Center, Israel, told Medscape Medical News.

"For clinicians, this means that in these patients, we should start with psychotherapy and withhold antidepressant treatment because many patients will respond to psychotherapy."

If the postpartum depression does not improve after a month, antidepressant therapy can be added, he said. "Even though our results failed to demonstrate an advantage with add-on sertraline, our small sample size means that we cannot exclude the possibility that some women in our study actually responded to the drug, and not psychotherapy."

Limited Data on Postpartum Depression Pharmacotherapy

Postpartum depression has been reported in from 10% to 20% of women and causes profound acute distress in about 10% to 15% of them, Dr. Bloch said. No figures are available on how many women with postpartum depression in the acute setting will progress to chronic depression.

In turn, their offspring may be at increased risk for developmental problems such as attention deficit hyperactivity disorder, as well as psychiatric illnesses during adulthood, and may also develop lower stress tolerance, Dr. Bloch noted.

Although postpartum depression is actually a form of major depression, its etiology is probably related to a combination of biological and psychological factors. The condition is more common after the first childbirth.

Most women do not seek treatment at all, and those women who are treated are usually prescribed antidepressants because they are cheaper and more accessible than psychotherapy. However, there are limited data on the use of pharmacotherapy in this population, with only 1 blinded and placebo-controlled study (using fluoxetine), and several studies without a placebo group. In addition, there is a complete absence of data on combination treatment with antidepressants and psychotherapy.

In contrast to the paucity of drug studies in women with postpartum depression, several studies have documented the efficacy of psychotherapy in this population. In fact, favorable results have been reported for cognitive, dynamic, and interpersonal psychotherapy, among others.

Sertraline Shows No Benefit

The present study included 42 women aged 18 to 45 years who had a Structured Clinical Interview for Diagnostic Services Manual IV diagnosis of major depression of mild to moderate severity.

Individuals who were suicidal, treatment-resistant, and reported depression for longer than 6 months were ineligible.

All participants underwent 12 consecutive sessions of brief, focused, dynamic psychotherapy delivered by psychotherapists.

The women were also randomly assigned to receive 8 weeks' concurrent treatment with sertraline or placebo. Sertraline was started at 50 mg/day for 4 weeks, after which a 100 mg/day dose could be substituted for the next 4 weeks, based on the clinical judgment of the treating psychiatrist. The blinded medication was followed by a 4-week open-label phase.

Results showed that most women, irrespective of their treatment assignment, improved during the course of the study. There was no advantage at any time point to add-on sertraline.

The response rates were 70% for the drug group and 55% for the placebo group (chi square, .96; P = .33, not significant), and remission rates at 8 weeks were 65% for the drug group and 50% for the placebo group (chi square, .92; P = .34, not significant).

Dr. Bloch cautioned that potential study limitations include the small sample size, short duration of treatment, and relatively low dose of the study drug. "It is possible that higher dose sertraline may be more effective than the lower dose; however, this possibility needs to be tested," he said.

In addition, the study excluded women with severe postpartum depression. "It may be that severely depressed women have a stronger treatment response, but this, too, has not been demonstrated," Dr. Bloch added.

Finally, the Israeli investigator expressed doubt that another selective serotonin reuptake inhibitor would yield different results. "Perhaps other types of antidepressants may have a role, but we haven't examined this possibility," he said.

His group is now looking at whether the hormonal status of women during the postpartum period may enhance the role of psychological factors in the pathophysiology of postpartum depression.

Hope for the Future

"It's important to study postpartum depression because the condition is common and may have consequences for the mother and her offspring," Celso Arango, MD, who is head of the adolescent unit in the psychiatry division at hospital General Universitario Gregorio Marañón, in Madrid, Spain, and also associate professor of psychiatry at the Maryland Psychiatric Research Center of the University of Maryland in Baltimore, told Medscape Medical News.

"I think this study is interesting because it suggests that psychotherapy by itself is sufficient in nonsevere cases," he said. "However, it's important to emphasize that, at least for now, this study will not change how I treat my patients with postpartum depression because the sample size was small. The study did not include a placebo-only group, but it's clear that the inclusion of a placebo-only group was not possible for ethical reasons. In addition, a type 2 error cannot be excluded. The investigators acknowledged all these possible shortcomings."

"If the results hold up in future studies, then it means that we don't need to use a psychotropic drug in women with postpartum depression. This would be good news," he added. "For now, if I see a woman I think might benefit from a trial with an antidepressant, I will go ahead and prescribe it until the data convincingly show me otherwise."

The study was funded by the National Alliance for Research on National Alliance for Research on Schizophrenia and Depression. Dr. Bloch and Dr. Arango have disclosed no relevant financial relationships.

24th Congress of the European College of Neuropsychopharmacology (ECNP): Abstract P.2.a.010. Presented September 5, 2011.

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