RE104 Safety and Efficacy Study in Postpartum Depression

Launched by REUNION NEUROSCIENCE INC · Mar 26, 2024

Keywords

ClinConnect Summary

The RE104 Safety and Efficacy Study is a clinical trial designed to see if a single injection of a new treatment called RE104 can help reduce symptoms of postpartum depression (PPD) in women who are experiencing moderate to severe depression after giving birth. This study is currently looking for women aged 18 to 45 who have given birth within the past 12 months and meet specific criteria for depression. Participants should not be using any psychiatric medications or therapies for at least 30 days before joining the study and must not be breastfeeding at the time of screening.

If you qualify and decide to participate, you will receive either the RE104 treatment or a placebo (which looks like the treatment but does not contain the active ingredient) and will be monitored for changes in your depressive symptoms. The study aims to find out how effective RE104 is compared to the placebo. It’s important to know that certain medical and mental health conditions may exclude you from participating, so the research team will carefully assess your eligibility. This trial is an opportunity to contribute to important research that could help other women facing similar challenges in the future.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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.