A Phase 2 interventional study of RE104 for Injection in Adjustment Disorder, sponsored by Reunion Neuroscience Inc. Recruiting at 33 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
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.
63 studies on the registry are indexed under Adjustment Disorders; 13 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 52 interventional studies indexed under Adjustment Disorders.
Browse Adjustment Disorders studies →Reunion Neuroscience Inc is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Nov 10, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Not enrolling at this site — choose another above.
Plan to share: No — Data sharing will be consistent with the results submission policy of ClinicalTrials.gov
No publications or documents are linked to this record.
Started Jul 2025 (actual). Primary completion is estimated for Apr 2027, 21 months after the start.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 10, 2026: primary completion Nov 2026 → Apr 2027 and completion Dec 2026 → May 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Reunion Neuroscience Inc