A Phase 2 interventional study of RE104 for Injection and Placebo in Generalized Anxiety Disorder, sponsored by Reunion Neuroscience Inc. Recruiting at 28 sites in United States. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Reunion Neuroscience Inc · Phase 2, Interventional, and Treatment
The purpose of this study is to determine if treatment with a single and/or repeat dose of RE104 for Injection reduces anxiety symptoms in participants with Generalized Anxiety Disorder (GAD) as compared to placebo.
517 studies on the registry are indexed under Generalized Anxiety Disorder; 124 are open to participants now.
This study's planned enrollment of 160 is above the median of 83 across 439 interventional studies indexed under Generalized Anxiety Disorder.
Browse Generalized Anxiety Disorder 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.
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.
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.
A single subcutaneous injection of 0.9% sodium chloride for injection per dosing session
Drug: Placebo
A single subcutaneous injection of 30 mg RE104 for Injection per dosing session
Drug: RE104 for Injection
Single dose (Part A) or Repeat-dose (Part B), subcutaneous injection(s) of RE104 for Injection
Single-dose (Part A) or Repeat-dose (Part B), subcutaneous injection(s) of 0.9% sodium chloride for injection
RE104 when administered as a single 30 mg dose or as two 30 mg doses 3 weeks apart versus placebo change from Baseline at Week 4 in Hamilton Anxiety Rating Scale (HAM-A) total score
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: Week 4
RE104 versus placebo 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: Weeks 1, 2, 8 and 12
RE104 versus placebo percentage of participants with HAM-A response (≥50% reduction in score from Baseline)
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: Weeks 1, 2, 4, 8 and 12
RE104 versus placebo percentage of participants with HAM-A remission (total score ≤7)
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 1 and Weeks 1, 2, 4, 8 and 12
RE104 versus placebo change from Baseline at Weeks 1, 2, 4, 8, and 12 in Hospital Anxiety and Depression Scale (HADS) depression subscore
The Hospital Anxiety and Depression Scale (HADS) is a self-reported scale measure the severity of depression and anxiety in patients with comorbid medical conditions. The scale consists of 14 items (7 for anxiety and 7 for depression), with a score ranging between 0 and 21 for the anxiety and depression subscales.
Time frame: Weeks 1, 2, 4, 8 and 12
RE104 versus placebo 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 12 weeks)
RE104 versus placebo change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) (Part B only)
The 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: Weeks 1, 2, 4, 8, and 12
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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 Apr 2026 (actual). Primary completion is estimated for Jul 2027, 15 months after the start.
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Generalized Anxiety Disorder →
Reunion Neuroscience Inc