RecruitingPhase 2interventionalRules rewrite

Phase 2: testing RE104 for Injection for Generalized Anxiety Disorder

This study wants 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 dummy treatment (placebo).

Official registry: https://clinicaltrials.gov/study/NCT07489651 · Reunion Neuroscience Inc · enrollment listed as 160

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are RE104 for Injection, or Placebo. The registry lists allocation as randomized. This study wants 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 dummy treatment (placebo).

They plan to enroll about 160 people at 28 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of RE104 for Injection in the Treatment of Generalized Anxiety Disorder

Interventions: RE104 for Injection, Placebo

Primary outcome (registry wording): 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

Who it is for (from inclusion criteria)

Ages 18 Years to 74 Years
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

Who the registry excludes

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

Public study contact (from the registry)

Mark Pollack Chief Medical Officer, M.D.

1-888-880-REUN

info@reunionneuro.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

28 listed

University of Alabama (UAB) Clinical Research Unit (CRU) — Birmingham, Alabama (recruiting)
Lighthouse Psychiatry — Gilbert, Arizona (recruiting)
Preferred Research Partners, Inc. — Little Rock, Arkansas (recruiting)
Collaborative Neuroscience Research, LLC — Garden Grove, California (recruiting)
Kadima Neuropsychiatry Institute — La Jolla, California (recruiting)
Open Mind Therapeutics — San Francisco, California (recruiting)
TRIP Clinic at Psychedelic Science Institute — Santa Monica, California (recruiting)
Innovative Clinical Research, Inc. — Lauderhill, Florida (recruiting)
University of South Florida — Tampa, Florida (recruiting)
Atlanta Center for Medical Research — Atlanta, Georgia (recruiting)
CenExel iResearch, LLC — Decatur, Georgia (recruiting)
Evergreen Clinical Trials — Norcross, Georgia (recruiting)

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FAQ about this NCT record

Is NCT07489651 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07489651?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07489651?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary