RightFit
RecruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether one injection of RE104 can reduce depression, with or without anxiety, compared with an active placebo. It is for people with adjustment disorder—trouble coping with a stressful event—caused by cancer or certain other illnesses.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have adjustment disorder with depression, or depression and anxiety, for at least 4 weeks, confirmed in a clinical interview.
  • The disorder must be caused by cancer, ALS, MS, Parkinson’s disease, or IPF. ALS, MS, and Parkinson’s affect nerves or movement; IPF causes lung scarring.
  • Can move around and care for yourself well enough to complete study tasks.
  • Have normal thinking and memory skills.
  • Have steady use of antidepressant medicine or talk therapy, or are willing to wait until the study ends to start.
  • If female, are not pregnant or planning pregnancy. If male, are not planning to get a partner pregnant.
  • Are willing and able to follow study rules.

Who can't join

  • Have a serious risk of suicide.
  • Have or have had bipolar disorder, schizophrenia, schizoaffective disorder, a psychotic disorder, or borderline personality disorder. These conditions affect mood, sense of reality, or relationships.
  • Have a parent, sibling, or child with psychosis (loss of touch with reality) or bipolar disorder.
  • Have or have had cancer in the brain or spinal cord.
  • Have another serious health condition that makes the study unsuitable for you.
  • Have used or will need medicines or treatments that the study does not allow.
  • Have a known sensitivity to, or cannot tolerate, the study treatment or medicines that may be needed to manage a reaction.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 sites (32)

AL

AZ

CA

CO

FL

GA

HI

IL

KS

LA

MA

MD

MI

NC

NE

NM

NY

OH

PA

TN

TX

UT

VA

WA

WI