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RE104 for Adjustment Disorder in Cancer and Other Medical Illnesses

This study is testing a single dose of RE104 for Injection to see if it can help reduce symptoms of depression or mixed anxiety and depression. This is for people who have Adjustment Disorder (a condition where you have strong emotional or behavioral reactions to a stressful event or change) because of a medical illness like cancer, ALS (Amyotrophic Lateral Sclerosis), MS (Multiple Sclerosis), Parkinson's Disease (PD), or IPF (Idiopathic Pulmonary Fibrosis). The study will compare RE104 for Injection to an active-placebo (a treatment that looks like the study drug but doesn't have the active ingredient). Researchers will measure changes in your depression symptoms after 7 days to see if the treatment is effective. The study plans to include 100 participants aged 18 to 80 years old.

Study design
This study is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 100 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at Day 7 after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07002034

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

Recruiting
PHASE2Ages 18–80InterventionalTreatment
Reunion Neuroscience Inc
~100 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:RE104 for Injection

At a glance

Recruiting sites
32 of 32 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
RE104 30 mg versus RE104 1.5 mg change from baseline in MADRS total score
Measured over Day 7

Conditions

Adjustment Disorder

Explore related trials

Adjustment DisorderAmyotrophic Lateral SclerosisIdiopathic Pulmonary FibrosisMalignant NeoplasmMultiple SclerosisParkinson Disease

Where it's being run

32 sites across 25 states
California2
Illinois2
Maryland2
Massachusetts2
Michigan2
New York2
Ohio2
Alabama1

Study leadership

  • Mark Pollack, Chief Medical Officer · STUDY_DIRECTOR · Reunion Neuroscience Inc

Who to contact

Mark Pollack, Chief Medical Officer
[email protected]
1-888-880-REUN
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • RE104 30 mg versus RE104 1.5 mg change from baseline in MADRS total scoreDay 7

    Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician rated scale measuring depression severity. The total score ranges from 0-60 with higher scores representing greater severity of depression.