RE104 for Injection in Generalized Anxiety Disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2 interventional trial evaluating RE104 for Injection versus placebo in adults with Generalized Anxiety Disorder. Participants may receive a single dose or multiple doses, and outcomes will compare anxiety symptom changes to placebo. The study will monitor safety and tolerability alongside efficacy signals. Eligible sites include a university clinic in Birmingham, AL, an outpatient psychiatry center in Gilbert, AZ, and partner research programs in Little Rock, AR. The trial excludes individuals with certain psychiatric histories or significant medical risks that could affect participation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

• University of Alabama (UAB) Clinical Research Unit (CRU)
  Birmingham, Alabama, United States Recruiting
• Lighthouse Psychiatry
  Gilbert, Arizona, United States Recruiting
• Preferred Research Partners, Inc.
  Little Rock, Arkansas, United States Recruiting
• Collaborative Neuroscience Research, LLC
  Garden Grove, California, United States Recruiting
• Kadima Neuropsychiatry Institute
  La Jolla, California, United States Recruiting
• Open Mind Therapeutics
  San Francisco, California, United States Recruiting

Study contacts

• Study coordinator: Mark Pollack Chief Medical Officer, M.D.
• Email: info@reunionneuro.com
• Phone: 1-888-880-REUN

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.