This study will test if one dose of RE104, given at different dose levels, can safely help with adjustment disorder in people with cancer and other medical illnesses.
To join this study, you will first have a visit to see if you qualify. You will have medical and mental health exams to find out if you can join the study. If you join, you will be randomly placed into one of two groups. You won’t know which dose level you get, and neither will the study staff. This is called “double-blind.” You will get one or two dose levels, either the 30mg dose or 1.5 mg dose. Both doses will be given “subcutaneously”, meaning that it’s injected into the fatty part of the upper arm, like a vaccine. To take part, you must come to in-person visits for screening, dosing day, and follow-up visits. These visits include medical history, physical exams, heart tests (ECG), safety checks like blood and urine tests, and mental health assessments. You will also have remote follow-up study visits for psychological tests, which will be done online or over the phone. After your medicine session, you must have a support person with you to help you. The screening period will take a maximum of 28 days. If you are eligible to join, the study will take 42 days. In total, you can anticipate participating for a maximum of 70 days.
You may be able to join if you: • Have a cancer diagnosis or other serious medical illness including amyotrophic lateral sclerosis, multiple sclerosis, Parkinson’s disease, or idiopathic pulmonary fibrosis. • Have ongoing depression, anxiety, or feelings of hopelessness • Can take care of yourself and have no serious organ problems • Are 18 years old or older
Protocol Number: 25-0813
More information available at ClinicalTrials.gov: NCT07002034
Principal Investigator