EPDS

Curio Digital Therapeutics Inc. Announces the U.S. Food and Drug Administration (FDA) Clearance of MamaLift Plus™, the First Prescription Digital Therapeutic Authorized for the Treatment of Postpartum Depression (PPD)

Retrieved on: 
Tuesday, April 23, 2024
Mental Health, Women, FDA, Baby, Maternity, Clinical Trials, Biotechnology, Health, Consumer, Pharmaceutical, American College, Regulation, PPD, Woman, Behavioral activation, Food, Cognitive behavioral therapy, BAT, Depression, DBT, Smartphone, Summer, ACOG, Therapy, Edinburgh Postnatal Depression Scale, Patient, MPH, Postpartum depression, Face, ITT, IPT, RCT, Dialectical behavior therapy, CBT, EPDS

Curio Digital Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has granted clearance to MamaLift PlusTM.

Key Points: 
  • Curio Digital Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has granted clearance to MamaLift PlusTM.
  • MamaLift Plus treats mild to moderate postpartum depression by improving a patient’s symptoms of depression.
  • MamaLift Plus delivers digital Cognitive Behavioral Therapy (CBT), Behavioral Activation Therapy (BAT), Interpersonal Therapy (IPT), and Dialectical Behavior Therapy (DBT) for postpartum depression.
  • The clearance of MamaLift Plus is based on results from the Supporting Maternal Mental Health and Emotional Regulation (SuMMER).

Curio Digital Therapeutics: Pivotal Trial for Postpartum Depression Digital Therapeutic Meets Efficacy Endpoints

Retrieved on: 
Friday, October 6, 2023
Mental Health, Health, Consumer, Women, Baby, Maternity, Biotechnology, Diagnosis, Edinburgh Postnatal Depression Scale, Digital, Woman, Regulation, ITT, Summer, Patient, Pharmaceutical industry, EPDS

Curio Digital Therapeutics, Inc. (“Curio”), today announced positive data from the Supporting Maternal Mental Health and Emotional Regulation (SuMMER) trial.

Key Points: 
  • Curio Digital Therapeutics, Inc. (“Curio”), today announced positive data from the Supporting Maternal Mental Health and Emotional Regulation (SuMMER) trial.
  • SuMMER (NCT05958095), a study executed by HITLAB, a renowned healthcare innovation and research organization, is a randomized clinical trial of MamaLift Plus, a digital therapeutic for women experiencing perinatal mood disturbances.
  • Patients had baseline EPDS scores ≥ 13 but not exceeding 19, and a confirmed diagnosis of postpartum depression prior to enrollment.
  • The SuMMER trial met its primary endpoint, a ≥4-point improvement in Edinburgh Postnatal Depression Scale (EPDS) score.