Clinical trial NCT06342310: RE104 Safety and Efficacy Study in Postpartum Depression
Official title: 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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Postpartum Depression
Lead sponsor: Reunion Neuroscience Inc
Sponsor class: INDUSTRY
First posted: 2024-04-02
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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-placebo.


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.

Primary outcomes:
measure: RE104 30 mg versus RE104 1.5 mg change from baseline in MADRS total score
timeFrame: Day 7
Secondary outcomes:
measure: RE104 30 mg versus RE104 1.5 mg change from baseline in MADRS total score
timeFrame: Day 1, Day 14 and Day 28
measure: RE104 30 mg versus RE104 1.5 mg percentage of patients with MADRS response (≥ 50 percent reduction in score from baseline)
timeFrame: Day 7
measure: RE104 30 mg versus RE104 1.5 mg percentage of patients with MADRS remission (score ≤ to 10)
timeFrame: Day 7
measure: RE104 30 mg versus RE104 1.5 mg Clinical Global Impression-Improvement (CGI-I)
timeFrame: Day 1, Day 7 and Day 28
measure: RE104 30 mg versus RE104 1.5 mg change from baseline in CGI-Severity (CGI-S)
timeFrame: Day 1, Day 7 and Day 28
measure: RE104 30 mg versus RE104 1.5 mg changes in total score from baseline in Hamilton Anxiety Rating Scale (HAM-A)
timeFrame: Day 7
measure: RE104 30 mg versus RE104 1.5 mg incidence of treatment-emergent adverse events (TEAEs) by frequency, severity and seriousness.
timeFrame: From dosing through study completion (post-dose follow-up is for 28 days)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Reunion Investigational Site
state: Alabama
city: Tucson
country: United States
facility: Reunion Investigational Site
state: Arizona
city: Santa Monica
country: United States
facility: Reunion Investigational Site
state: California
city: Boulder
country: United States
facility: Reunion Investigational Site
state: Colorado
city: Denver
country: United States
facility: Reunion Investigational Site
state: Colorado
city: Lauderhill
country: United States
facility: Reunion Investigational Site
state: Florida
city: Tampa
country: United States
facility: Reunion Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Reunion Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: Reunion Investigational Site
state: Georgia
city: Decatur
country: United States
facility: Reunion Investigational Site
state: Georgia
city: Marietta
country: United States
facility: Reunion Investigational Site
state: Georgia
city: Savannah
country: United States
facility: Reunion Investigational Site
state: Georgia
city: Honolulu
country: United States
facility: Reunion Investigational Site
state: Hawaii
city: Kansas City
country: United States
facility: Reunion Investigational Site
state: Kansas
city: Shreveport
country: United States
facility: Reunion Investigational Site
state: Louisiana
city: Baltimore
country: United States
facility: Reunion Investigational Site
state: Maryland
city: Rockville
country: United States
facility: Reunion Investigational Site
state: Maryland
city: Springfield
country: United States
facility: Reunion Investigational Site
state: Massachusetts
city: Novi
country: United States
facility: Reunion Investigational Site
state: Michigan
city: Albuquerque
country: United States
facility: Reunion Investigational Site
state: New Mexico
city: Buffalo
country: United States
facility: Reunion Investigational Site
state: New York
city: New York
country: United States
facility: Reunion Investigational Site
state: New York
city: New York
country: United States
facility: Reunion Investigational Site
state: New York
city: Chapel Hill
country: United States
facility: Reunion Investigational Site
state: North Carolina
city: Monroe
country: United States
facility: Reunion Investigational Site
state: North Carolina
city: Cleveland
country: United States
facility: Reunion Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Reunion Investigational Site
state: Ohio
city: West Chester
country: United States
facility: Reunion Investigational Site
state: Pennsylvania
city: Austin
country: United States
facility: Reunion Investigational Site
state: Texas
city: Austin
country: United States
facility: Reunion Investigational Site
state: Texas
city: Austin
country: United States
facility: Reunion Investigational Site
state: Texas
city: Plano
country: United States
facility: Reunion Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Reunion Investigational Site
state: Texas
city: Draper
country: United States
facility: Reunion Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: Reunion Investigational Site
state: Utah
city: Charlottesville
country: United States
facility: Reunion Investigational Site
state: Virginia
city: Seattle
country: United States
facility: Reunion Investigational Site
state: Washington
city: Madison
country: United States
facility: Reunion Investigational Site
state: Wisconsin
Study officials:
affiliation: Reunion Neuroscience Inc
name: Jasna Hocevar-Trnka, M.D.
role: STUDY_DIRECTOR
References: