A Phase 2 interventional study of RE104 for Injection in Adjustment Disorder, sponsored by Reunion Neuroscience Inc. Recruiting at 32 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Reunion Neuroscience Inc · Phase 2, Interventional, and Treatment
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.
Exclusion Criteria:
A single subcutaneous injection of 1.5 mg RE104 for Injection
Drug: RE104 for Injection
A single subcutaneous injection of 30 mg RE104 for Injection
Drug: RE104 for Injection
Single, subcutaneous dose of RE104 for Injection
RE104 30 mg versus RE104 1.5 mg change from baseline in MADRS total score
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.
Time frame: Day 7
RE104 30 mg versus RE104 1.5 mg changes in total score from baseline in Hamilton Anxiety Rating Scale (HAM-A)
The Hamilton Rating Scale for Anxiety (HAM-A) is a 14-item scale that is used to rate the severity of symptoms of anxiety. The total score ranges from 0-56 with higher scores representing greater severity of anxiety.
Time frame: Day 7
RE104 30 mg versus RE104 1.5 mg incidence of treatment-emergent adverse events (TEAEs) by frequency, severity and seriousness.
A treatment-emergent adverse event (TEAE) is defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a study drug.
Time frame: From dosing through study completion (post-dose follow-up is for 42 days)
Plan to share: No — Data sharing will be consistent with the results submission policy of ClinicalTrials.gov
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Reunion Neuroscience Inc