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Single-dose RE104 injection for adjustment disorder in people with cancer or certain chronic 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

Phase 2 Interventional Reunion Neuroscience Inc · NCT07002034

This trial tests whether a single injection of RE104 reduces depressive or mixed anxiety–depression symptoms in people with adjustment disorder related to cancer, ALS, MS, Parkinson's disease, or idiopathic pulmonary fibrosis.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment100 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorReunion Neuroscience Inc Industry-sponsored
Locations28 sites (Birmingham, Alabama and 27 other locations)
Trial IDNCT07002034 on ClinicalTrials.gov

What this trial studies

This Phase 2 interventional trial gives eligible participants a single dose of RE104 for Injection and compares symptom change to an active placebo. Participants must have at least a four-week history of adjustment disorder with depressed mood or mixed anxiety and depression triggered by a qualifying medical illness and must be ambulatory with normal cognition. Concomitant antidepressants or psychotherapy are allowed if stable, or can be delayed until study end, and people with high suicide risk or primary psychotic or bipolar disorders are excluded. Recruitment occurs at three U.S. sites and standardized clinical rating scales will be used to measure changes in depressive and anxiety symptoms.

Who should consider this trial

Good fit: Ideal candidates are ambulatory adults with at least four weeks of DSM-5-TR–defined adjustment disorder presenting with depressed mood or mixed anxiety–depressed mood triggered by cancer, ALS, MS, Parkinson's disease, or IPF, who have normal cognition and are willing to maintain or delay other psychiatric treatments per protocol.

Not a fit: Patients with significant suicide risk, active or past bipolar disorder, schizophrenia, schizoaffective disorder, other primary psychotic disorders, borderline personality disorder, pregnancy, major cognitive impairment, or inability to travel to a study site are unlikely to be eligible or to benefit from this protocol.

Why it matters

Potential benefit: If effective, RE104 could provide a rapid, single-dose option to reduce depressive or mixed anxiety–depression symptoms in medically ill patients with adjustment disorder.

How similar studies have performed: Single-dose, rapid-acting neuropsychiatric treatments (for example ketamine) have shown benefit for depressive symptoms in other populations, but RE104 itself is experimental and prior efficacy for adjustment disorder has not been established.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Birmingham, Alabama and 27 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Adjustment DisorderCancerAmyotrophic Lateral SclerosisMultiple SclerosisParkinson&amp#39s DiseaseIdiopathic Pulmonary Fibrosis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.