Summary:
Segal Trials is currently conducting a clinical research study evaluating the safety and efficacy of a Digital Therapeutic Adjunct Treatment for patients with Postpartum Depression.
A Multicenter, Randomized, Double-Blind, Controlled Study Evaluating the Efficacy and Safety of a Digital Therapeutic as an Adjunct to Treatment as Usual Among Women with Mild to Moderate Postpartum Depression
Criteria:- Women Ages 22 to 45 years old
- Must be ≤ 92 days postpartum at time of screening
- Onset of MDE anytime during pregnancy or within 4 weeks following delivery according to DSM-5 diagnostic criteria
- Mild to Moderate depression; HAM-D score of > 7 and < 13 at screening
- Must be receiving stable treatment (medication and/or psychotherapy) for 4 weeks prior to screen
- No BMI criteria!
- History of ketamine/esketamine, ECT, VNS, or DBS treatment is exclusionary
- Distinct symptoms of PPD may also include: intense irritability/anger, mood swings, guilt, and difficulty bonding with the baby (in addition to other common symptoms related to a MDE)
- Must own or have regular access to a smartphone and has reliable Wi-Fi access or sufficient data plan to engage with assigned treatment condition for the duration of the study
- Must have primary residence in the US
- Must be willing to comply with all study procedures and restrictions
- Must be able to understand and willing to provide informed consent
Qualified Participants May Receive:
- Complimentary Study Related Exams & Lab Work.
- Complimentary Transportation
- Compensation for time and travel