RE104 Safety and Efficacy Study in Adjustment Disorder in Cancer and Other Medical Illnesses

NCT ID
NCT07002034
Registry status
Recruiting
Study type
Not specified in the registry data
Phase
Phase 2
Sponsor
Reunion Neuroscience Inc

Overview

ClinicalTrials.gov lists this study as Recruiting.

Enrollment: 100 participants (Estimated).

What is being studied

No interventions are listed in the registry data.

Who may be eligible

Ages
Not specified in the registry data
Sex
Not specified in the registry data
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion Criteria: * 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 Criteria: * 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

Study locations

32 study locations are listed.

Site recruitment status is not specified in the registry data for these locations.

Countries: United States

  • Alabama, United States: 1
  • Arizona, United States: 1
  • California, United States: 2
  • Colorado, United States: 1
  • Florida, United States: 1
  • Georgia, United States: 1
  • Hawaii, United States: 1
  • Illinois, United States: 2
  • Kansas, United States: 1
  • Louisiana, United States: 1
  • Maryland, United States: 2
  • Massachusetts, United States: 2
  • Michigan, United States: 2
  • Nebraska, United States: 1
  • New Mexico, United States: 1
  • New York, United States: 2
  • North Carolina, United States: 1
  • Ohio, United States: 2
  • Pennsylvania, United States: 1
  • Tennessee, United States: 1
  • Texas, United States: 1
  • Utah, United States: 1
  • Virginia, United States: 1
  • Washington, United States: 1
  • Wisconsin, United States: 1

Sample of listed locations

  • UAB, Psychiatry and Behavioral Neurology — Birmingham, Alabama, 35209, United States — Site recruitment status not specified in the registry data
  • University of Arizona — Tucson, Arizona, 85724, United States — Site recruitment status not specified in the registry data
  • Kadima Neuropsychiatry Institute — San Diego, California, 92037, United States — Site recruitment status not specified in the registry data
  • Providence Medical Foundation — Santa Rosa, California, 95403, United States — Site recruitment status not specified in the registry data
  • University of Colorado — Aurora, Colorado, 80045, United States — Site recruitment status not specified in the registry data
  • University of South Florida, Department of Psychiatry and Behavioral Neuroscience — Tampa, Florida, 33613, United States — Site recruitment status not specified in the registry data
  • Emory University — Atlanta, Georgia, 30329, United States — Site recruitment status not specified in the registry data
  • Hawaii Pacific Neuroscience — Honolulu, Hawaii, 96817, United States — Site recruitment status not specified in the registry data
  • Rush University Medical Center — Chicago, Illinois, 60612, United States — Site recruitment status not specified in the registry data
  • University of Chicago Medical Center — Chicago, Illinois, 60637, United States — Site recruitment status not specified in the registry data
  • The University of Kansas Medical Center — Kansas City, Kansas, 66160, United States — Site recruitment status not specified in the registry data
  • LSU Health Shreveport — Shreveport, Louisiana, 71103, United States — Site recruitment status not specified in the registry data
  • Sunstone Therapies, PC — Rockville, Maryland, 20850, United States — Site recruitment status not specified in the registry data
  • Sheppard Pratt — Towson, Maryland, 21204, United States — Site recruitment status not specified in the registry data
  • Dana Farber Cancer Institute — Boston, Massachusetts, 02215, United States — Site recruitment status not specified in the registry data
  • University of Massachusetts Chan Medical Center — Worcester, Massachusetts, 01655, United States — Site recruitment status not specified in the registry data
  • University of Michigan — Ann Arbor, Michigan, 48109, United States — Site recruitment status not specified in the registry data
  • Henry Ford Health — Novi, Michigan, 48377, United States — Site recruitment status not specified in the registry data
  • University of Nebraska Medical Center — Omaha, Nebraska, 68198, United States — Site recruitment status not specified in the registry data
  • University of New Mexico, School of Medicine — Albuquerque, New Mexico, 87131, United States — Site recruitment status not specified in the registry data
  • Roswell Park Center Institute — Buffalo, New York, 14263, United States — Site recruitment status not specified in the registry data
  • NYU Langone Health — New York, New York, 10016, United States — Site recruitment status not specified in the registry data
  • University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, 27514, United States — Site recruitment status not specified in the registry data
  • Cleveland Clinic — Cleveland, Ohio, 44113, United States — Site recruitment status not specified in the registry data
  • The Ohio State University, Department of Psychiatry — Columbus, Ohio, 43210, United States — Site recruitment status not specified in the registry data

Study details

Start date
July 30, 2025
Primary completion date
November 1, 2026
First posted
June 3, 2025

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07002034
Registry last updated
September 15, 2026
QualifiedStudies registry data refreshed
September 21, 2026

View NCT07002034 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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