Postpartum depression digital therapeutic shows positive results in clinical trial

Curio Digital Therapeutics has announced positive clinical trial data for its postpartum depression digital therapeutic.

MamaLift Predict is a validated algorithm that has demonstrated success in identifying and stratifying women at risk for postpartum depression.

SuMMER, a study executed by HITLAB, assessed MamaLift Plus for eight weeks in 141 patients using the Edinburgh Postnatal Depression Scale (EPDS).

The EPDS is a clinically-validated tool that healthcare providers use to evaluate, diagnose, and monitor depression in pregnant and postpartum women. Scores 13 and above indicate depressive illness or a high risk of developing a depressive disorder.

Patients involved in the MamaLift Predict trial had baseline EPDS scores 13 and above but not exceeding 19, and a confirmed diagnosis of postpartum depression prior to enrollment.

The SuMMER study found that patients treated with MamaLift Plus showed a four or more points improvement in their EPDS scores. An improvement of four or more points is considered clinically meaningful.

Preliminary results indicated that approximately 83 per cent of participants in the intervention arm achieved a four or more points improvement in EPDS score, compared to only 22 per cent in the control arm.

Professor Stan Kachnowski, principal investigator and HITLAB chair, said: “We are excited to see the data on this critical research endeavour.

“The positive results from the SuMMER trial underscore the efficacy of MamaLift Plus to address postpartum depression and improve the lives of women experiencing perinatal mood disturbance.

“Our collaboration exemplifies HITLAB’s commitment to advancing women’s healthcare innovations, and we look forward to continuing to drive positive change in the field of digital therapeutics and mental health through rapid evidence generation.”

More than one in 10 women will experience postpartum depression after giving birth, with some studies reporting as many as one in seven women. However, researchers believe the condition is much more common than the data reveals.

Younger mothers, aged 25 and below, are thought to be more likely to develop postpartum depression or anxiety.

Shailja Dixit, chief executive officer at Curio, said: “We are delighted and encouraged by the strong findings from the SuMMER study.

“Digital therapeutics continue to be an important option for women suffering from depressive symptoms. We are profoundly grateful to the study participants and the research team for their contributions to this research.

“We look forward to continued guidance from the FDA to bring this important intervention to market.”