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RE104 for Postpartum Depression

Phase 2
Recruiting
Research Sponsored by Reunion Neuroscience Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, day 14 and day 28
Awards & highlights

Summary

This trial aims to see if giving one dose of RE104 for Injection can help reduce symptoms of postpartum depression in people with moderate to severe symptoms, compared to a placebo.

Who is the study for?
This trial is for individuals who are within 12 months postpartum and have moderate-to-severe depression. They must not be breastfeeding, meet specific criteria on the Hamilton Depression Scale, and either be free from psychotropic medications and psychotherapy for 30 days or on a stable regimen of SSRIs or therapy.
What is being tested?
The study tests whether a single dose of RE104 for Injection can reduce depressive symptoms in those with postpartum depression compared to an active-placebo. It aims to see if this new treatment is safe and effective.
What are the potential side effects?
While the side effects are not explicitly listed here, typical reactions may include discomfort at injection site, potential allergic reactions, mood swings, headaches, nausea or other common medication-related side effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, day 14 and day 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, day 14 and day 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
RE104 30 mg versus RE104 1.5 mg Clinical Global Impression-Improvement (CGI-I)
RE104 30 mg versus RE104 1.5 mg change from baseline in CGI-Severity (CGI-S)
RE104 30 mg versus RE104 1.5 mg change from baseline in MADRS total score
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: 30 mg RE104Experimental Treatment1 Intervention
A single subcutaneous injection of 30 mg RE104 for Injection
Group II: 1.5 mg RE104Active Control1 Intervention
A single subcutaneous injection of 1.5 mg RE104 for Injection

Find a Location

Who is running the clinical trial?

Reunion Neuroscience IncLead Sponsor
Jasna Hocevar-Trnka, M.D.Study DirectorReunion Neuroscience Inc
~48 spots leftby May 2025
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