Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Reunion Neuroscience Inc
Age
18–45
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Is ≤15 months postpartum at Screening.
Meet DSM-5 criteria for postpartum depression (PPD): experiencing a major depressive episode that began at any time starting at the beginning of the second trimester (≥14 weeks) of pregnancy through 4 weeks post delivery.
Has a Hamilton Depression Scale (HAM-D) total score meeting severity threshold at Screening and Baseline.
Is not using any psychotropic medications or psychotherapy for 30 days prior to Screening, OR are on an already stable/established regimen of SSRIs or psychotherapy for 30 days prior to Screening.
Has ceased breastfeeding at Screening.
Has a negative pregnancy test at Screening and Day 0 prior to study drug administration.
You may not be if
History or active postpartum psychosis per Investigator assessment.
History of treatment-resistant depression within the current postpartum depressive episode.
Has a significant risk of suicide.
Active or medical history of bipolar disorder, schizophrenia, schizoaffective disorder, psychotic disorder and/or borderline personality disorder, or first-degree family history of psychosis or bipolar disorder.
Medically significant condition rendering unsuitability for the study .
Has received electroconvulsive therapy (ECT) or transcranial magnetic stimulation within 90 days prior to Screening.
Has used psychedelics such as psilocybin, ayahuasca, mescaline, or LSD (with the exception of cannabis) within 12 months prior to Screening.
Has used or will need to use prohibited medications.
