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NCT Number: NCT07489651

RE104 Safety and Efficacy Study in Generalized Anxiety Disorder

The purpose of this study is to determine if treatment with a single dose of RE104 for Injection reduces anxiety symptoms in participants with Generalized Anxiety Disorder (GAD) as compared to placebo.

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Key information

Conditions

Generalized Anxiety Disorder Anxiety Disorders Mental Disorders

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Lighthouse Psychiatry, Gilbert, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RE104 for Injection

Drug

Single, subcutaneous dose of RE104 for Injection

Placebo

Drug

Single, subcutaneous dose of 0.9% sodium chloride for injection

Primary outcomes

  1. RE104 30 mg versus placebo change from Baseline at Week 4 in Hamilton Anxiety Rating Scale (HAM-A) total score

    Time frame: Week 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.

Secondary outcomes

  1. RE104 30 mg versus placebo changes in total score from baseline in Hamilton Anxiety Rating Scale (HAM-A)

    Time frame: Weeks 1, 2, 8 and 12

    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.

  2. RE104 30 mg versus placebo percentage of participants with HAM-A response (≥50% reduction in score from Baseline)

    Time frame: Weeks 1, 2, 4, 8 and 12

    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.

  3. RE104 30 mg versus placebo percentage of participants with HAM-A remission (total score ≤7)

    Time frame: Day 1 and Weeks 1, 2, 4, 8 and 12

    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.

  4. RE104 30 mg versus placebo change from Baseline at Weeks 1, 2, 4, 8, and 12 in Hospital Anxiety and Depression Scale (HADS) depression subscore

    Time frame: Weeks 1, 2, 4, 8 and 12

    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.

  5. RE104 30 mg versus placebo incidence of treatment-emergent adverse events (TEAEs) by frequency, severity and seriousness.

    Time frame: From dosing through study completion (post-dose follow-up is for 12 weeks)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mark Pollack Chief Medical Officer, M.D.

CONTACT

[email protected]

1-888-880-REUN

Sponsors and collaborators

Lead sponsor

Reunion Neuroscience Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 24, 2026
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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