RE104 Safety and Efficacy Study in Postpartum Depression

Postpartum Depression Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06342310
• Other study ID #: RE104-201-PPD
• Status: Recruiting
• Phase: Phase 2
• Start date: June 14, 2024
• Est. completion date: June 2025

Study information

• Verified date: March 2024
• Source: Reunion Neuroscience Inc
• Contact: Jasna Hocevar-Trnka, M.D.
• Phone: 1-888-880-REUN
• Email: info[@]reunionneuro.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: June 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Is =12 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.

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Postpartum Depression

Intervention

Drug:
• RE104 for Injection
Single, subcutaneous dose of RE104 for Injection

Locations

Country	Name	City	State
United States	Reunion Investigational Site	Decatur	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Reunion Neuroscience Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RE104 30 mg versus RE104 1.5 mg change from baseline in MADRS total score	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.	Day 7
Secondary	RE104 30 mg versus RE104 1.5 mg change from baseline in MADRS total score	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.	Day 1, Day 14 and Day 28
Secondary	RE104 30 mg versus RE104 1.5 mg percentage of patients with MADRS response (= 50 percent reduction in score from baseline)	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.	Day 7
Secondary	RE104 30 mg versus RE104 1.5 mg percentage of patients with MADRS remission (score = to 10)	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.	Day 7
Secondary	RE104 30 mg versus RE104 1.5 mg Clinical Global Impression-Improvement (CGI-I)	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).	Day 1, Day 7 and Day 28
Secondary	RE104 30 mg versus RE104 1.5 mg change from baseline in CGI-Severity (CGI-S)	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).	Day 1, Day 7 and Day 28
Secondary	RE104 30 mg versus RE104 1.5 mg changes in total score from baseline in Hamilton Anxiety Rating Scale (HAM-A)	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.	Day 7
Secondary	RE104 30 mg versus RE104 1.5 mg incidence of treatment-emergent adverse events (TEAEs) by frequency, severity and seriousness.	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.	From dosing through study completion (post-dose follow-up is for 28 days)