RE104 Safety and Efficacy Study in Adjustment Disorder in Cancer and Other Medical Illnesses
NCT ID: NCT07002034
Last Updated: 2025-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
100 participants
INTERVENTIONAL
2025-07-30
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1.5 mg RE104
A single subcutaneous injection of 1.5 mg RE104 for Injection
RE104 for Injection
Single, subcutaneous dose of RE104 for Injection
30 mg RE104
A single subcutaneous injection of 30 mg RE104 for Injection
RE104 for Injection
Single, subcutaneous dose of RE104 for Injection
Interventions
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RE104 for Injection
Single, subcutaneous dose of RE104 for Injection
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Reunion Neuroscience Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Mark Pollack, Chief Medical Officer
Role: STUDY_DIRECTOR
Reunion Neuroscience Inc
Locations
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UAB, Psychiatry and Behavioral Neurology
Birmingham, Alabama, United States
University of Arizona
Tucson, Arizona, United States
Kadima Neuropsychiatry Institute
San Diego, California, United States
Providence Medical Foundation
Santa Rosa, California, United States
University of Colorado
Aurora, Colorado, United States
University of South Florida, Department of Psychiatry and Behavioral Neuroscience
Tampa, Florida, United States
Hawaii Pacific Neuroscience
Honolulu, Hawaii, United States
LSU Health Shreveport
Shreveport, Louisiana, United States
Sunstone Therapies, PC
Rockville, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Henry Ford Health
Novi, Michigan, United States
University of New Mexico, School of Medicine
Albuquerque, New Mexico, United States
NYU Langone Center for Psychedelic Medicine
New York, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
The Ohio State University, Department of Psychiatry
Columbus, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Dell Medical School, University of Texas at Austin
Austin, Texas, United States
Cedar Clinical Research Inc.
Draper, Utah, United States
UVA Center for Psychiatric Clinical Research
Charlottesville, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RE104-202-ADCO
Identifier Type: -
Identifier Source: org_study_id
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