A Multicenter Randomized Double-Blind Parallel-Group Dose-Controlled Study Evaluating the Safety and Efficacy of RE104 for Injection in the Treatment of Patients with Postpartum Depression (PPD)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Postpartum Depression
  • Age: Between 18 Year(s) - 45 Year(s)
  • Gender: Female
  • Other Inclusion Criteria:
    1. Is 12 months postpartum at Screening and meets criteria for Postpartum Depression (PPD).
    2. Is not currently receiving and is willing to delay the use of any psychotropic pharmacotherapy regimens (including antidepressant or antianxiety medication), and/or psychotherapy (unless on already established psychotherapy for 30 days prior to Screening) until Day 7 study assessments have been completed. Patients should not discontinue current, adequate psychotropic treatment(s) for the sole purpose of enrollment into the study.
    3. Has ceased breastfeeding at Screening.
    4. Is using an effective and appropriate method of contraception at Screening and agrees to continue to use such a method throughout the duration of the study.
    5. Has a negative pregnancy test prior to study drug administration.
    6. Is willing and able to nominate a trusted caregiver who can assist in providing support, care, and attention to the patient’s infant(s) for the entirety of the dosing day (Day 0) through a 24-hour post-dose (Day 1) visit.

You may not be eligible for this study if the following are true:

    1. History of or active postpartum psychosis.
    2. History of treatment-resistant depression within the current postpartum depressive episode as defined by having previously failed to respond to adequate courses (e.g., doses for 4 weeks) of pharmacotherapy from 2 different classes of antidepressants.
    3. Has a significant risk of suicide or has attempted suicide within 12 months prior to the Screening Visit.
    4. 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.
    5. Active or medical history of seizures other than childhood febrile seizures.
    6. Exposure to another clinical study involving study treatment within 30 days prior to Screening.
    7. Administration of electroconvulsive therapy (ECT) or transcranial magnetic stimulation within 90 days prior to Screening and/or plans to administer ECT before the Study Day 28 Visit.
    8. Use of psychedelics such as psilocybin, ayahuasca, mescaline, or LSD (with the exception of cannabis) within 12 months prior to Screening.
    9. Initiated new psychotherapy (cognitive behavioral therapy) within 30 days prior to Screening.
    10. Current (within the last 12 months) alcohol or substance use disorder or positive urine drug screen for illicit drugs (including cannabis) or drugs of abuse at Screening or Day 0.
    11. Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (e.g., spouse, parent, child, sibling) or may consent under duress.



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