Zuranolone Bests Placebo in Postpartum Depression
At day 15, significantly greater reduction seen in depressive symptoms as measured by change in HAMD-17 score from baseline
WEDNESDAY, June 30, 2021 (HealthDay News) -- For women with postpartum depression, zuranolone improves symptoms of depression, as measured by the 17-item Hamilton Rating Scale for Depression (HAMD-17) score, according to a study published online June 30 in JAMA Psychiatry.
Kristina M. Deligiannidis, M.D., from Zucker Hillside Hospital in Glen Oaks and the Feinstein Institutes for Medical Research at Northwell Health in Manhasset -- both in New York, and colleagues conducted a randomized, outpatient trial involving women aged 18 to 45 years, no more than six months postpartum, with postpartum depression and a baseline HAMD-17 score of 26 or higher. Participants were randomly assigned to either placebo or zuranolone administered orally each evening for two weeks (76 and 77 participants, respectively).
The researchers observed a significant day-15 improvement in HAMD-17 score from baseline with zuranolone versus placebo (−17.8 versus −13.6; difference, −4.2). From day three through 45, sustained differences in HAMD-17 scores favoring zuranolone were observed (differences, −2.7 and −4.1, respectively). At day 15, there were sustained differences favoring zuranolone for HAMD-17 response (odds ratio, 2.63), HAMD-17 score remission (odds ratio, 2.53), change from baseline for Montgomery-Åsberg Depression Rating Scale score (difference, −4.6), and Hamilton Rating Scale for Anxiety score (difference, −3.9). One patient in each group experienced a serious adverse event. Due to an adverse event, one patient in the zuranolone group and none in the placebo group discontinued treatment.
"These encouraging results are an important step in efforts to develop a novel treatment option for patients who suffer from this prevalent condition," Deligiannidis said in a statement.
Several authors disclosed financial ties to pharmaceutical companies, including Sage Therapeutics, which manufactures zuranolone and funded the study. One author reports a patent pending for use of neuroactive steroids in the treatment of postpartum depression.