Postpartum depression (mother)

Depression after childbirth. Many new mothers have short spells of low mood, tearfulness or worry known as the baby blues, which usually pass within a few days to a week. Postpartum depression is more intense and lasts longer than two weeks, and it can begin anytime in the first year after the birth. It is common, serious and treatable.

Condition
In this atlas

Overview

Technical summary

MedlinePlus (from the Office on Women's Health) describes postpartum depression as a common but serious mood disorder that can begin anytime within the first year after childbirth, separate from the baby blues that go away within a few days to a week. NIMH treats it as the part of perinatal depression that follows birth. MedlinePlus lists talk therapy and medicines, including antidepressants, as treatments. US regulators have approved two medicines whose labelled use is postpartum depression: Zulresso (brexanolone) injection, given as a 60-hour infusion, labelled for adults in 2019 and for patients 15 years and older since a 2022 supplement, and now listed as discontinued; and Zurzuvae (zuranolone) capsules taken by mouth for 14 days, labelled for adults. The recipient is the postpartum woman.

Recognition

MedlinePlus lists feeling sad or empty most of the time, changes in eating and sleeping, crying more than usual, pulling away from family and friends, feeling little or no interest in the baby, constant doubts about caring for the baby, and thinking of harming oneself or the baby. Symptoms are more intense and last longer than the baby blues.

Assessment

MedlinePlus says a provider may use screening questions or questionnaires and a clinical evaluation based on symptoms, with blood tests if needed to check for physical conditions such as thyroid disorders.

Burden

No burden claims are published.

Claims and evidence

No claims are published for this condition yet.

Clinical links

Each link reports what one cited claim says about one population. "Evaluated for" means studied, not shown to work. These links do not show that anything is effective or right for you.

Claim, not a settled fact Treated by: Brexanolone (Claimed to treat, seen from the other side)
Applies to Maternal
- Women with postpartum depression and a qualifying 17-item Hamilton Rating Scale for Depression (HAM-D) score: 26 or more in study 1 (severe) and 20 to 25 in study 2 (moderate). They received a single 60-hour intravenous infusion of brexanolone or matching placebo.
- 30 clinical research centres and specialised psychiatric units (abstract).
- United States
- Up to 6 months post partum at screening, aged 18 to 45 years.
- Gestational age Not reported
- Postnatal age Not reported
Follow-up Followed until day 30; primary endpoint at 60 hours (abstract).
Two double-blind, placebo-controlled phase 3 trials of a single 60-hour intravenous infusion of brexanolone in postpartum depression randomized 138 women in study 1 (brexanolone 90 µg/kg per hour n=45, 60 µg/kg per hour n=47, placebo n=46) and 108 in study 2 (brexanolone 90 µg/kg per hour n=54, placebo n=54). In study 1, severe depression, the average fall in HAM-D total score at 60 hours was 19.5 points with the 60 µg/kg dose, 17.7 with the 90 µg/kg dose and 14.0 with placebo, differences from placebo of -5.5 (95% CI -8.8 to -2.2, p=0.0013) and -3.7 (95% CI -6.9 to -0.5, p=0.0252). In study 2, moderate depression, the fall was 14.6 points with the 90 µg/kg dose and 12.1 with placebo, a difference of -2.5 (95% CI -4.5 to -0.5, p=0.0160).
Source problem. A cited source is corrected. Check the sources before relying on this claim.
Limitations. Only the PubMed abstract was read. PubMed lists an erratum (PMID 30303081) that has no abstract and was not read, so these numbers are as printed in the abstract. The trials were funded by Sage Therapeutics (abstract funding line). Follow-up ended at day 30, the primary endpoint was a rating-scale change at the end of the infusion, and the trials excluded women with a history of schizophrenia, bipolar disorder or schizoaffective disorder. Study 2 tested one active dose, and study 1 also tested a lower dose. The abstract does not say which of these doses the marketed product uses; see the FDA label for dosing.
Claim, not a settled fact Treated by: Zuranolone (Claimed to treat, seen from the other side)
Applies to Maternal
- Women with severe postpartum depression who were randomized 1:1 to zuranolone 50 mg a day or placebo for 14 days. The registry gives the age range as 18 to 45 years and the sex as female. The abstract says severe postpartum depression but prints no score cut-off or onset window.
- Not stated in the abstract. The registry lists study sites in the United States, Spain and the United Kingdom.
- United States, Spain and United Kingdom (registry locations)
- Postpartum. The abstract and the registry fields read give no postnatal age limits.
- Gestational age Not reported
- Postnatal age Not reported
Follow-up 45-day study: 14 days of treatment, primary endpoint at day 15, secondary endpoints at days 3, 28 and 45 (abstract).
In SKYLARK, a double-blind phase 3 trial, 196 women with severe postpartum depression were randomized 1:1 to zuranolone 50 mg a day or placebo for 14 days (98 in each group), and 170 (86.7%) completed the 45-day study. At day 15, the primary endpoint, the average change from baseline in the 17-item Hamilton Depression Rating Scale (HAM-D) total score was -15.6 with zuranolone and -11.6 with placebo, a least-squares mean difference of -4.0 (95% CI -6.3 to -1.7). The authors report significant improvement at days 3, 28 and 45 too.
Source problem. A cited source is corrected. Check the sources before relying on this claim.
Limitations. Only the PubMed abstract was read, not the full paper. PubMed lists an erratum for the paper (PMID 39659161) that has no abstract and was not read, so these numbers are as printed in the abstract and may have been corrected. The registry names an industry lead sponsor (Biogen). The trial enrolled women with severe postpartum depression, so the result does not apply to milder illness. A rating-scale change at day 15 is not remission or relapse, and follow-up ended at day 45. The registry records 200 enrolled while the abstract prints 196 randomized; both counts are kept on the study page.
Claim, not a settled fact Treated by: Zulresso (brexanolone injection) (Claimed to treat, seen from the other side)
Applies to Maternal
- Women with postpartum depression and a qualifying 17-item Hamilton Rating Scale for Depression (HAM-D) score: 26 or more in study 1 (severe) and 20 to 25 in study 2 (moderate). They received a single 60-hour intravenous infusion of brexanolone or matching placebo.
- 30 clinical research centres and specialised psychiatric units (abstract).
- United States
- Up to 6 months post partum at screening, aged 18 to 45 years.
- Gestational age Not reported
- Postnatal age Not reported
Follow-up Followed until day 30; primary endpoint at 60 hours (abstract).
FDA's 2019 label for Zulresso, which words the indication as adults, says its efficacy in postpartum depression was shown in two multicenter, randomized, double-blind, placebo-controlled studies in women aged 18 to 45, where a 60-hour continuous intravenous infusion or placebo was followed by 4 weeks of follow-up. Study 1 (NCT02942004) included severe postpartum depression and Study 2 (NCT02942017) moderate postpartum depression. In both, the label says titration to a target dose of 90 µg/kg per hour was superior to placebo in improvement of depressive symptoms. The published abstract of these two trials reports average HAM-D falls at 60 hours of 17.7 and 14.6 points with the 90 µg/kg dose against 14.0 and 12.1 with placebo.
Source problem. A cited source is corrected. Check the sources before relying on this claim.
Limitations. This claim rests on the 2019 label, which FDA marks as possibly not the latest approved, and on the abstract of the Lancet paper, which has an erratum that was not read. The label states p values but this record uses only the label's qualitative statement. openFDA lists Zulresso as discontinued; this claim describes trial efficacy, not current availability. Efficacy in a trial is not a prediction for one person.
Claim, not a settled fact Treated by: Zurzuvae (zuranolone) (Claimed to treat, seen from the other side)
Applies to Maternal
- Women with severe postpartum depression who were randomized 1:1 to zuranolone 50 mg a day or placebo for 14 days. The registry gives the age range as 18 to 45 years and the sex as female. The abstract says severe postpartum depression but prints no score cut-off or onset window.
- Not stated in the abstract. The registry lists study sites in the United States, Spain and the United Kingdom.
- United States, Spain and United Kingdom (registry locations)
- Postpartum. The abstract and the registry fields read give no postnatal age limits.
- Gestational age Not reported
- Postnatal age Not reported
Follow-up 45-day study: 14 days of treatment, primary endpoint at day 15, secondary endpoints at days 3, 28 and 45 (abstract).
FDA states that the efficacy of Zurzuvae in adults with postpartum depression was shown in two randomized, double-blind, placebo-controlled, multicenter studies. The primary endpoint was the change in HAMD-17 total score at day 15, and the Zurzuvae groups showed significantly more improvement than the placebo groups. The current label names the first of the two studies (Study 1) as NCT04442503, the SKYLARK trial, whose published abstract reports -15.6 points with zuranolone 50 mg against -11.6 with placebo (difference -4.0, 95% CI -6.3 to -1.7). The label's recommended dose is 50 mg by mouth once a day in the evening for 14 days.
Source problem. A cited source is corrected. Check the sources before relying on this claim.
Limitations. This claim rests on FDA's press announcement of 2023 and the current label text in openFDA, plus the SKYLARK abstract. The label's Study 2 (NCT02978326) tested another zuranolone capsule formulation, approximately equivalent to 40 mg of Zurzuvae, and is not recorded in this atlas. The label and the abstract give different participant counts for Study 1, and the atlas does not reconcile them. The press announcement gives no numbers. The population is severe postpartum depression in the SKYLARK abstract and adults with postpartum depression in the label; this is not a statement about mild illness. Efficacy in a trial is not a prediction for one person. An erratum exists for the SKYLARK paper and was not read.

Record details

Record id: maternal:postpartum-depression
Content hash: 30b1182943fa5e4a3667b8abea77e60f6055df9ea8d7ac64912c78002eef9c89