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RE104 for Generalized Anxiety Disorder Study

This study is looking at whether a single dose of RE104 for Injection can help reduce anxiety symptoms in people with Generalized Anxiety Disorder (GAD). You would receive either RE104 for Injection or a placebo (an inactive substance like salt water). Researchers will measure your anxiety levels using a scale called the Hamilton Anxiety Rating Scale (HAM-A) at Week 4 to see if RE104 for Injection is more effective than placebo. This study is for adults aged 18 to 74 who have GAD as defined by DSM-5-TR (a diagnostic manual for mental health conditions). You cannot join if you have a high risk of suicide or a history of bipolar disorder. The current status of this study is unclear.

Study design
This is an interventional study comparing RE104 for Injection to a placebo. It plans to enroll 64 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your anxiety levels will be measured at Week 4 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.

NCT07489651

RE104 Safety and Efficacy Study in Generalized Anxiety Disorder

Recruiting
PHASE2Ages 18–74InterventionalTreatment
Reunion Neuroscience Inc
~64 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:RE104 for InjectionPlacebo

At a glance

Recruiting sites
28 of 28 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
RE104 30 mg versus placebo change from Baseline at Week 4 in Hamilton Anxiety Rating Scale (HAM-A) total score
Measured over Week 4

Conditions

Generalized Anxiety Disorder

Explore related trials

Generalized Anxiety Disorder

Where it's being run

28 sites across 17 states
California4
Georgia4
Texas3
Florida2
Pennsylvania2
Utah2
Alabama1
Arizona1

Study leadership

  • Mark Pollack, M.D. · STUDY_DIRECTOR · Reunion Neuroscience Inc

Who to contact

Mark Pollack Chief Medical Officer, M.D.
[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 Generalized Anxiety Disorder as defined by DSM-5-TR
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 an 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 other concurrent psychiatric disorders that is the primary disorder.
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 placebo change from Baseline at Week 4 in Hamilton Anxiety Rating Scale (HAM-A) total scoreWeek 4

    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.