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

NCT07002034

RecruitingPhase 2

Sponsor: Reunion Neuroscience Inc

Conditions: Adjustment Disorder

Interventions: RE104 for Injection

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (30)

Birmingham, Alabama, United States
Tucson, Arizona, United States
San Diego, California, United States
Santa Rosa, California, United States
Aurora, Colorado, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Honolulu, Hawaii, United States
Chicago, Illinois, United States
Kansas City, Kansas, United States
Shreveport, Louisiana, United States
Rockville, Maryland, United States
Towson, Maryland, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Novi, Michigan, United States
Omaha, Nebraska, United States
Albuquerque, New Mexico, United States
Buffalo, New York, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Philadelphia, Pennsylvania, United States
Knoxville, Tennessee, United States
Austin, Texas, United States
Draper, Utah, United States
Charlottesville, Virginia, United States
Seattle, Washington, United States
Madison, Wisconsin, United States