NCT07002034

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Reunion Neuroscience Inc · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adjustment Disorder

Interventions

Type	Name	Description
DRUG	RE104 for Injection	Single, subcutaneous dose of RE104 for Injection

Timeline

• Start date: 2025-07-30
• Primary completion: 2026-11-01
• Completion: 2026-12-01
• First posted: 2025-06-03
• Last updated: 2026-03-16

Locations

25 sites across 1 country: United States

Regulatory

• FDA-regulated drug study