RE104 for Adjustment Disorder
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called RE104 to determine its effectiveness in reducing depression or anxiety in people with Adjustment Disorder. It targets individuals with this condition due to serious illnesses like cancer, ALS, MS, Parkinson's, or IPF. Participants will receive either a high or low dose of RE104 as a single injection. Suitable candidates have had Adjustment Disorder for at least four weeks, are managing their illness, and are stable on antidepressants or therapy. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to the development of potentially effective therapies.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it mentions that you should be on stable use of antidepressants or psychotherapy, or be willing to delay starting them until the study ends.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that RE104 for Injection has been generally safe in earlier studies. In one study, participants tolerated doses up to 40 mg well, with no serious side effects or deaths reported. Most side effects occurred soon after treatment and were mild. Another study found that a 30 mg dose of RE104 was effective, with 77.1% of patients showing significant symptom improvement. Overall, these findings suggest that RE104 is well-tolerated.12345
Why do researchers think this study treatment might be promising for Adjustment Disorder?
Unlike the standard treatments for adjustment disorder, which often include therapy and medications like antidepressants or anti-anxiety drugs, RE104 offers a novel approach. Researchers are excited because RE104 is administered as a single subcutaneous injection, potentially offering faster relief. Moreover, it involves a unique mechanism of action, which could provide an alternative for those who don't respond well to traditional therapies. The excitement also stems from the possibility that RE104 might require less frequent dosing, making it a more convenient option for patients.
What evidence suggests that RE104 for Injection might be an effective treatment for Adjustment Disorder?
Research has shown that RE104 for Injection may help reduce symptoms of depression. One study found that 77.1% of patients who received a 30 mg dose of RE104 experienced a 50% reduction in depression symptoms within a week. In this trial, participants will receive either a 30 mg dose or a 1.5 mg dose of RE104. This treatment works similarly to psilocybin, known for improving mood, but its effects do not last as long. RE104 is also considered safe, making it a promising option for individuals with adjustment disorder due to illnesses like cancer or ALS. While more studies are needed, these early findings are encouraging.12367
Who Is on the Research Team?
Mark Pollack, Chief Medical Officer
Principal Investigator
Reunion Neuroscience Inc
Are You a Good Fit for This Trial?
This trial is for individuals with Adjustment Disorder experiencing depression or anxiety due to illnesses like cancer, ALS, MS, PD, or IPF. Participants must be diagnosed with one of these conditions and have symptoms of depression or anxiety.Inclusion Criteria
Exclusion 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 RE104 for Injection
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- RE104 for Injection
Find a Clinic Near You
Who Is Running the Clinical Trial?
Reunion Neuroscience Inc
Lead Sponsor