Postpartum Depression
Conditions
Brief summary
The purpose of this study is to determine if treatment with a single dose of RE104 for Injection reduces depressive symptoms in participants with moderate-to-severe postpartum depression (PPD) as compared to active-control.
Interventions
Single, subcutaneous dose of RE104 for Injection
Sponsors
Reunion Neuroscience Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RE104 30 mg versus RE104 1.5 mg change from baseline in MADRS total score | Day 7 | Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician rated scale measuring depression severity. The total score ranges from 0-60 with higher scores representing greater severity of depression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| RE104 30 mg versus RE104 1.5 mg percentage of patients with MADRS remission (score ≤ to 10) | Day 7 | Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician rated scale measuring depression severity. The total score ranges from 0-60 with higher scores representing greater severity of depression. |
| RE104 30 mg versus RE104 1.5 mg Clinical Global Impression-Improvement (CGI-I) | Day 1, Day 7 and Day 28 | The Clinical Global Impression - Improvement (CGI-I) Scale is a clinician-rated instrument that weighs the clinical impact of the identified symptom(s) on behavior and function and measures changes in psychopathology since the treatment was administered on a scale from 1 (very much improved) to 7 (very much worse). |
| RE104 30 mg versus RE104 1.5 mg change from baseline in CGI-Severity (CGI-S) | Day 1, Day 7 and Day 28 | The Clinical Global Impression - Severity Scale is a clinician-rated instrument that grades severity of symptoms on a scale from 1 (normal, not ill at all) to 7 (among the most extremely ill patients). |
| RE104 30 mg versus RE104 1.5 mg changes in total score from baseline in Hamilton Anxiety Rating Scale (HAM-A) | Day 7 | The Hamilton Rating Scale for Anxiety (HAM-A) is a 14-item scale that is used to rate the severity of symptoms of anxiety. The total score ranges from 0-56 with higher scores representing greater severity of anxiety. |
| RE104 30 mg versus RE104 1.5 mg incidence of treatment-emergent adverse events (TEAEs) by frequency, severity and seriousness. | From dosing through study completion (post-dose follow-up is for 28 days) | A treatment-emergent adverse event (TEAE) is defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a study drug. |
| RE104 30 mg versus RE104 1.5 mg percentage of patients with MADRS response (≥ 50 percent reduction in score from baseline) | Day 7 | Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician rated scale measuring depression severity. The total score ranges from 0-60 with higher scores representing greater severity of depression. |
| RE104 30 mg versus RE104 1.5 mg change from baseline in MADRS total score | Day 1, Day 14 and Day 28 | Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician rated scale measuring depression severity. The total score ranges from 0-60 with higher scores representing greater severity of depression. |
Countries
United States
Contacts
STUDY_DIRECTORJasna Hocevar-Trnka, M.D.
Reunion Neuroscience Inc
Outcome results
None listed