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

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Interventional

Phase

Phase 2

Age range

18 years - 80 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

100 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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 may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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 a history of current active 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

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

Triple masked

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (33)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

33 locations

Study team and timeline

Lead sponsor

Reunion Neuroscience Inc

Study start

Jul 30, 2025 Actual

Primary completion

2027-04 Estimated

Study completion

2027-05 Estimated

First posted

Jun 3, 2025 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts