[Study Evaluating the Efficacy and Safety of a Digital Therapeutic as an Adjunct to TAU in Postpa… (NCT05551195) | Clinical Trial Compass
TerminatedNot Applicable
[Study Evaluating the Efficacy and Safety of a Digital Therapeutic as an Adjunct to TAU in Postpartum Depression]
Stopped: Internal company decision
United States7 participantsStarted 2022-11-16
Plain-language summary
This study evaluates the efficacy of two digital therapeutics, WB001 and ED001, on depressive symptoms among women diagnosed with postpartum depression.
Who can participate
Age range22 Years – 45 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Must have primary residence in the United States
✓. Must be ≤ 92 days postpartum
✓. Must be women aged 22-45 years who had onset of a major depressive episode any time during pregnancy or within 4 weeks following delivery
✓. Must own or have regular access to a smartphone (Android or iOS smartphone with a recent, supported operating system), and has reliable Wi-Fi access or sufficient data plan to engage with assigned treatment condition for the duration of the study
✓. Participants must have current mild-moderate depression as measured by the HAMD-6 score \>7 and \<13 at screening
✓. Participant must have a form of TAU, defined as clinician supervised outpatient care management and includes follow-up visits, medication, psychotherapy, or some combination thereof
✓. TAU must be regularly scheduled or stable for at least 4 weeks prior to baseline (BL) visit
Exclusion criteria
✕. Gestation less than 28 weeks
✕. HAMD-6 score ≤7 or ≥13 (severe depression) at screening
✕. Currently pregnant or plans to become pregnant within the next 8 weeks
✕. History of drug and/or alcohol use disorder within the past 12 months
✕. Lifetime history of suicide attempt or ideation with a plan and intent to harm oneself during the current episode of PPD
What they're measuring
1
Hamilton Rating Scale for Depression (HAM-D)
Timeframe: Change from Baseline to Post-treatment at Week 8
✕. Current or lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, and/or homicidal or infanticidal ideation
✕. History of antidepressant treatment with ketamine/esketamine, electroconvulsive therapy, vagal nerve stimulation, or a deep brain stimulation device