Status:
RECRUITING
RE104 Safety and Efficacy Study in Adjustment Disorder in Cancer and Other Medical Illnesses
Lead Sponsor:
Reunion Neuroscience Inc
Conditions:
Adjustment Disorder
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
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 with anxiety symptoms in participants with Adj...
Eligibility Criteria
Inclusion
- Has a ≥4 week history of AjD as defined by DSM-5-TR with either depressed mood, or mixed anxiety and depressed mood confirmed by clinical interview with evidence that the AjD was instigated by one of the following medical illnesses (e.g., diagnosis, impact, management, recurrence, prognosis): Cancer, ALS, MS, PD or IPF
- Is sufficiently ambulatory and capable of self care as necessary to complete study procedures
- Has normal cognitive function
- Is on stable use of antidepressants or psychotherapy, or is willing to delay use until the end of study
- If female is not pregnant or planning to become pregnant. If male is not planning to make a partner pregnant
- Is willing and able to comply with the conditions and requirements of the study
Exclusion
- Has a significant risk of suicide
- Has 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
- Has active or a history of central nervous system malignancy
- Has other medically significant conditions rendering unsuitability for the study
- Has used or will need to use prohibited medications or therapies
- Has a known sensitivity or intolerance to study intervention or potential rescue medications
Key Trial Info
Start Date :
July 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07002034
Start Date
July 30 2025
End Date
December 1 2026
Last Update
December 15 2025
Active Locations (19)
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1
UAB, Psychiatry and Behavioral Neurology
Birmingham, Alabama, United States, 35209
2
University of Arizona
Tucson, Arizona, United States, 85724
3
Kadima Neuropsychiatry Institute
San Diego, California, United States, 92037
4
Providence Medical Foundation
Santa Rosa, California, United States, 95403