RecruitingPhase 2

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

United States100 participantsStarted 2025-07-30

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This is a Phase 2 trial, which means RE104 is still in relatively early testing — can you help me understand what that means for how much is already known about its safety and whether it actually works for adjustment disorder in people with cancer or other serious illnesses?
2The trial is comparing a 30 mg dose of RE104 against a very low 1.5 mg dose, and it's measuring changes in depression symptoms using something called the MADRS score — can you explain what RE104 is, how it's thought to help with adjustment disorder, and what that low-dose comparison tells us about how the study is designed?
3Since this trial is specifically for adjustment disorder related to cancer or other medical illnesses, do you think my current diagnosis and situation would even make me worth discussing as a potential candidate, and are there standard treatments I should consider trying first?
4What would participating in this trial actually require of me in terms of visits, monitoring, or any restrictions on other treatments I might be receiving for my underlying illness?
5If I were to discuss enrolling in this trial with you, how would it fit alongside or potentially conflict with the other medical care I'm already getting for my condition?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

RE104 30 mg versus RE104 1.5 mg change from baseline in MADRS total score

Timeframe: Day 7

Trial details

NCT IDNCT07002034

SponsorReunion Neuroscience Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-11

Contact for this trial

Mark Pollack, Chief Medical Officer

1-888-880-REUN info@reunionneuro.com

View on ClinicalTrials.gov More Adjustment Disorder trials