RE104 for Anxiety
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether a single dose of RE104 for Injection can reduce anxiety symptoms in people with Generalized Anxiety Disorder (GAD). Participants will receive either RE104 or a placebo (a harmless substance resembling the treatment) to compare effects. This trial suits those diagnosed with GAD who experience regular anxiety impacting daily life. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Is there any evidence suggesting that RE104 for Injection is likely to be safe for humans?
Earlier research found RE104 to be safe and easy to handle when administered as a single shot. This study showed no serious side effects, which is reassuring. Another study with a 30 mg dose of RE104 also found it was well-tolerated, with only mild side effects reported. Serious negative effects were rare or absent. These findings suggest that RE104 could be a safe option for those considering participation in a clinical trial for anxiety.12345
Why do researchers think this study treatment might be promising for anxiety?
Unlike the standard treatments for anxiety, which often include oral medications like SSRIs or benzodiazepines, RE104 is administered as a single subcutaneous injection. This is a novel delivery method that could offer quicker onset of effects compared to traditional oral pills. Researchers are particularly excited about RE104 because it may work differently, potentially targeting anxiety through a unique mechanism of action that could provide relief when other medications fall short. This innovative approach could mean faster, more efficient treatment options for those struggling with anxiety.
What evidence suggests that RE104 for Injection might be an effective treatment for anxiety?
Research has shown that RE104 for Injection may help treat anxiety. In earlier studies, a single 30 mg dose of RE104 quickly and lastingly improved depression symptoms. This trial will test a 30 mg dose of RE104 for its potential effects on anxiety, as anxiety and depression often share symptoms. Specifically, 71.4% of participants in that study reported significant relief from their symptoms after using RE104. Additionally, the treatment proved safe, with no serious side effects reported. These findings suggest that RE104 could be an effective and safe option for relieving anxiety.23456
Who Is on the Research Team?
Mark Pollack, M.D.
Principal Investigator
Reunion Neuroscience Inc
Are You a Good Fit for This Trial?
This trial is for adults diagnosed with Generalized Anxiety Disorder who are either on stable antidepressants or therapy, or willing to delay starting them. Participants must not be pregnant or planning pregnancy and should be able to follow study requirements.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single subcutaneous injection of either 30 mg RE104 or placebo
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- RE104 for Injection
Trial Overview
The study tests whether a single dose of RE104 injection can reduce anxiety symptoms compared to a placebo (inactive treatment) in people with Generalized Anxiety Disorder.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
A single subcutaneous injection of 30 mg RE104 for Injection
A single subcutaneous injection of 0.9% sodium chloride for injection
Find a Clinic Near You
Who Is Running the Clinical Trial?
Reunion Neuroscience Inc
Lead Sponsor
Citations
Met Primary Endpoint with 30mg Dose of RE104 ...
โThese data demonstrate the totality of RE104's rapid and durable impact โ across a range of physician- and patient-reported outcomes and ...
RE104 Safety and Efficacy Study in Adjustment Disorder in ...
The purpose of this study is to determine if treatment with a single dose of RE104 for Injection reduces depressive symptoms or depressive symptoms mixed ...
3.
contemporaryobgyn.net
contemporaryobgyn.net/view/re104-30-mg-demonstrates-efficacy-and-safety-in-new-phase-2-data-for-postpartum-depressionRE104 30 mg demonstrates efficacy and safety in new ...
A single 30 mg dose of RE104 produced rapid and sustained reductions in depressive symptoms in women with moderate-to-severe postpartum ...
Safety, Tolerability, Pharmacokinetics, and ... - PMC
SC doses of RE104 were generally safe up to 40 mg with no serious adverse events (AEs) or deaths. Most AEs occurred acutely under supervision ...
Reunion Neuroscience Announces Program Updates and ...
... RE104 can safely deliver clinically meaningful improvements in depression and anxiety scores. These results unlock a blockbuster opportunity in PPD, where ...
6.
psychiatrictimes.com
psychiatrictimes.com/view/re104-a-novel-fast-acting-psychedelic-for-postpartum-depressionRE104: A Novel, Fast-Acting Psychedelic for Postpartum ...
Phase 1 study showed RE104's safety and tolerability, with no serious adverse effects, supporting its use in postpartum depression treatment.
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