UPCC 26925 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

Investigating an Investigational Medication for Stress-Related Emotional or Behavioral Symptoms in Patients with Cancer and Other Illnesses

Enrolling By Invitation
18 years - 80 years
All
Phase 2
100 participants needed
1 Location

Brief description of study

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 of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Adjustment Disorder
  • Age: 18 years - 80 years
  • Gender: All

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

This study investigates the use of an investigational medication to treat Adjustment Disorder (AjD) in patients with cancer and other medical conditions such as Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Parkinson's Disease (PD), or Idiopathic Pulmonary Fibrosis (IPF). The purpose of this study is to assess whether a single dose of the investigational medication can reduce symptoms of depression or anxiety in these patients compared to an active placebo.

Participants in the study will receive either the investigational medication or an active placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who receives the investigational medication or the placebo. This helps ensure the results are not biased. All participants will be monitored for safety and efficacy of the treatment, with assessments conducted at various points during the study.

  • Who can participate: Participants must have had Adjustment Disorder for at least four weeks due to cancer or other specified illnesses and should be ambulatory, capable of self-care, with normal cognitive function. They must be on stable antidepressant use or willing to delay it, and women should not be pregnant, nor men planning pregnancy with a partner.
  • Study details: Participants will receive a single dose of the investigational medication or an active placebo, which is an inactive substance that looks like the investigational medicine but contains no active medicine. They must comply with study requirements and conditions.
Updated on 03 Jun 2026. Study ID: 25-1258
If you need assistance finding a non-cancer clinical research study or if you have any questions, please email psom-ocr@pobox.upenn.edu For Cancer trials contact Penn Medicine's Cancer Trial Navigator at: PMCancerResearch@pennmedicine.upenn.edu or 215-349-8245

Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.

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