Tests RE104 injection for adjustment disorder in people with cancer or other serious illnesses
Tests a single RE104 injection in adults with adjustment disorder from cancer or other illnesses.
Plain-language title generated from the registry record
Registry title: RE104 Safety and Efficacy Study in Adjustment Disorder in Cancer and Other Medical Illnesses
Key facts
- Where
- Albuquerque, Ann Arbor, Atlanta, Aurora, Austin, Birmingham, Boston, Buffalo, Chapel Hill, Charlottesville, Chicago, Cleveland, Columbus, Draper, Honolulu, Kansas City, Knoxville, Madison, New York, Novi, Omaha, Philadelphia, Rockville, San Diego, Santa Rosa, Seattle, Shreveport, Tampa, Towson, Tucson, and Worcester, United StatesSee the 33 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07002034, who can take part
Where in United States
- University of New Mexico, School of MedicineAlbuquerque, United StatesTaking people
- University of MichiganAnn Arbor, United StatesTaking people
- Emory UniversityAtlanta, United StatesTaking people
- University of ColoradoAurora, United StatesTaking people
- Dell Medical School, University of Texas at AustinAustin, United StatesTaking people
- UAB, Psychiatry and Behavioral NeurologyBirmingham, United StatesTaking people
- Dana-Farber Cancer InstituteBoston, United StatesTaking people
- Roswell Park Center InstituteBuffalo, United StatesTaking people
- University of North Carolina at Chapel HillChapel Hill, United StatesTaking people
- UVA Center for Psychiatric Clinical ResearchCharlottesville, United StatesTaking people
- Rush University Medical CenterChicago, United StatesTaking people
- University of Chicago Medical CenterChicago, United StatesTaking people
- Cleveland ClinicCleveland, United StatesTaking people
- The Ohio State University, Department of PsychiatryColumbus, United StatesTaking people
- Cedar Clinical Research Inc.Draper, United StatesTaking people
- Hawaii Pacific NeuroscienceHonolulu, United StatesTaking people
- The University of Kansas Medical CenterKansas City, United StatesTaking people
- Alliance for Multispecialty Research ClinicalKnoxville, United StatesTaking people
- University of Wisconsin at MadisonMadison, United StatesTaking people
- New York State Psychiatric InstituteNew York, United StatesTaking people
- NYU Langone HealthNew York, United StatesTaking people
- Henry Ford HealthNovi, United StatesTaking people
- University of Nebraska Medical CenterOmaha, United StatesTaking people
- University of PennsylvaniaPhiladelphia, United StatesTaking people
- Sunstone Therapies, PCRockville, United StatesTaking people
- Kadima Neuropsychiatry InstituteSan Diego, United StatesTaking people
- Providence Medical FoundationSanta Rosa, United StatesNo longer taking part
- Seattle Neuropsychiatric Treatment CenterSeattle, United StatesTaking people
- LSU Health ShreveportShreveport, United StatesTaking people
- University of South Florida, Department of Psychiatry and Behavioral NeuroscienceTampa, United StatesTaking people
- Sheppard PrattTowson, United StatesTaking people
- University of ArizonaTucson, United StatesTaking people
- University of Massachusetts Chan Medical CenterWorcester, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Reunion Neuroscience Inc
- Trial code
- NCT07002034
- Record updated
- 10 November 2026
- Original description
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 Adjustment Disorder due to cancer or other illnesses such as Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Parkinson's Disease (PD) or Idiopathic Pulmonary Fibrosis (IPF) as compared to active-placebo.Read full original descriptionShow less
A Randomized, Double-Blind, Parallel-Group, Dose-Controlled Study Evaluating the Safety and Efficacy of RE104 for Injection in the Treatment of Adjustment Disorder in Patients With Cancer and Other Medical Illnesses
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 Adjustment Disorder due to cancer or other illnesses such as Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Parkinson's Disease (PD) or Idiopathic Pulmonary Fibrosis (IPF) as compared to active-placebo.
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 used or will need to use prohibited medications or therapies; Has a known sensitivity or intolerance to study intervention or potential rescue medications; 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 a history of current active central nervous system malignancy; Has other medically significant conditions rendering unsuitability for the study; Has a significant risk of suicide.