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

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

Status
Active
Cancer Type
Solid Tumor
Trial Phase
Phase II
Eligibility
18 - 80 Years, Male and Female
Study Type
Treatment
NCT ID
NCT07002034
Protocol IDs
RE104-202-ADCO (primary)
NCI-2025-04106
Study Sponsor
Reunion Neuroscience Inc

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 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

  1. 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
  2. Is sufficiently ambulatory and capable of self care as necessary to complete study procedures
  3. Has normal cognitive function
  4. Is on stable use of antidepressants or psychotherapy, or is willing to delay use until the end of study
  5. If female is not pregnant or planning to become pregnant. If male is not planning to make a partner pregnant
  6. Is willing and able to comply with the conditions and requirements of the study

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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