Generalized Anxiety DisorderPhase 2NCT07489651
RE104 Safety and Efficacy Study in Generalized Anxiety Disorder
A Phase 2 study testing RE104 for Injection in people with Generalized Anxiety Disorder, run by Reunion Neuroscience Inc at 28 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- RE104 for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 28 sitesUnited States
- Study dates
- 20 Apr 2026to Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 cannot join
- 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
Trial locations and contacts
28 sites in 1 country. Contact the study team or a site near you to ask about taking part.
28 sites in 1 country
United States28 sites, 27 recruiting
- Recruiting
UNM Research Program Psychedelic Therapies
Albuquerque, New Mexico, 14624
Hector Garcia, 505-675-0582, hecgarcia@salud.unm.edu
- Recruiting
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
Amber Tannahill, 404-881-5800, a.tannahill@cenexel.com
- Recruiting
Austin Clinical Trial Partners
Austin, Texas, 78737
Kara Chilek, 512-521-0595, studyinfo@austinCTP.com
- Recruiting
BioBehavioral Research Austion
Austin, Texas, 78759
Tracie Wesson, 402-934-0044, tracie.wesson@qcrnetwork.com
- Recruiting
University of Alabama (UAB) Clinical Research Unit (CRU)
Birmingham, Alabama, 35209
Seher Premani, spremani@uab.edu, spremani@uab.edu
- Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
Julia Hoffman, julia_hoffmann1@med.unc.edu
- Recruiting
Uptown Research Institute
Chicago, Illinois, 60640
Deborah Jones-Miller, 773-989-8313 ext. 117, Djones-miller@uptownresearch.com
- Recruiting
CenExel iResearch, LLC
Decatur, Georgia, 30030
Michael Mahaffrey, m.mahaffrey@cenexel.com
- Recruiting
Cedar Clinical Research
Draper, Utah, 84020
Jane Bjorklund, 801-369-4219, jane.bjorklund@numinusnetwork.com
- Recruiting
Collaborative Neuroscience Research, LLC
Garden Grove, California, 92845
CNS Outreach Department, 844-424-9494, cns.outreach@cenexel.com
- Recruiting
Lighthouse Psychiatry
Gilbert, Arizona, 85234
Matt Longson, 435-268-5800, Contact@neosciclinicalresearch.com
- Recruiting
Kadima Neuropsychiatry Institute
La Jolla, California, 92037
Angelica Lu, 858-775-2053, angelical@kadimanp.com
- Recruiting
Innovative Clinical Research, Inc.
Lauderhill, Florida, 33319
Melissa Rodco, 305-722-8444, mrodco@segaltrials.com
- Recruiting
Preferred Research Partners, Inc.
Little Rock, Arkansas, 72211
Stacy Tierney, 501-553-9987 ext. 111, stierney@preferredresearchpartners.com
- Recruiting
NYU-H+C Clinical and Translational Science Institute
New York, New York, 10016
Jillian Kelly, 212-404-7764, Jillian.kelly@nyulangone.org
- Recruiting
Evergreen Clinical Trials
Norcross, Georgia, 30092
Stephen Wheeler, 943-230-1385, stephen@evergreenstrials.com
- Recruiting
Neuro-Behavioral Clinical Research, Inc.
North Canton, Ohio, 44720
Crystal Blackford, 330-493-1118, cblackford@nb-cr.com
- Recruiting
Henry Ford Medical Center - Columbus
Novi, Michigan, 48377
Madeline Bross, 248-344-7366, mbross1@hfhs.org
- Recruiting
Inner Space State Street
Orem, Utah, 84058
Janet Jimenez, 801-871-5516, apply@innerspaceresearch.com
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Erin Blase, 215-746-6419, erin.blase@pennmedicine.upenn.edu
- Recruiting
Aim Trials, LLC
Plano, Texas, 75093
Sonia Prashar, 214-856-2778, sonia.prashar@aimtrials.com
- Recruiting
Summit Headlands LLC
Portland, Oregon, 97210
Tyler Leecing, tyler.leecing@summitnetwork.com
- Recruiting
Midwest Research Group
Saint Charles, Missouri, 63304
Lindsay vanWinkle, 636-946-8032 ext. 3, lvanwinkle@midwestresearchgroup.com
- Recruiting
Open Mind Therapeutics
San Francisco, California, 94114
Victoria Vega, 415-906-7399, victoria@openmindcollective.org
- Recruiting
TRIP Clinic at Psychedelic Science Institute
Santa Monica, California, 90404
Ashley Ramos, trialadmin@psychedlicsci.com
- Recruiting
CenExel iResearch, LLC
Savannah, Georgia, 31405
Michelle Lagares, 912-744-0800, M.Lagares@CenExel.com
- Recruiting
University of South Florida
Tampa, Florida, 33613
Genesis Estramera, 813-974-1404, gestramera@usf.edu
- Withdrawn
Suburban Research Associates
West Chester, Pennsylvania, 19380
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of RE104 for Injection in the Treatment of Generalized Anxiety Disorder
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.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- RE104 for Injection, Placebo
- Keywords
- GAD
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RE104 for InjectionDrug
Single dose (Part A) or Repeat-dose (Part B), subcutaneous injection(s) of RE104 for Injection
PlaceboDrug
Single-dose (Part A) or Repeat-dose (Part B), subcutaneous injection(s) of 0.9% sodium chloride for injection
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | A single subcutaneous injection of 0.9% sodium chloride for injection per dosing session Receives: Drug: Placebo |
| 30 mg RE104 | Experimental | A single subcutaneous injection of 30 mg RE104 for Injection per dosing session Receives: Drug: RE104 for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 4
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Weeks 1, 2, 4, 8, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start20 Apr 2026
- Primary completionJul 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reunion Neuroscience Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Pollack, M.D., Study director, Reunion Neuroscience Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07489651
- Sponsor's protocol ID
- RE104-203-GAD
- Status last verified
- Sep 2026
- First submitted
- 18 Mar 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of RE104 for Injection in the Treatment of Generalized Anxiety Disorder
- ClinicalTrials.gov ID
- NCT07489651
- Acronym / sponsor ID
- RE104-203-GAD
- Conditions
- Generalized Anxiety Disorder
- Keywords
- GAD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Reunion Neuroscience IncIndustry (pharma, biotech, devices)
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboA single subcutaneous injection of 0.9% sodium chloride for injection per dosing session |
| 30 mg RE104 | Experimental | Drug: RE104 for InjectionA single subcutaneous injection of 30 mg RE104 for Injection per dosing session |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RE104 for InjectionSingle dose (Part A) or Repeat-dose (Part B), subcutaneous injection(s) of RE104 for Injection | Drug | 30 mg RE104 |
| PlaceboSingle-dose (Part A) or Repeat-dose (Part B), subcutaneous injection(s) of 0.9% sodium chloride for injection | Drug | Placebo |
Primary outcome
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
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.
6 secondary outcomes
RE104 versus placebo changes in total score from baseline in Hamilton Anxiety Rating Scale (HAM-A)
Time frame: Weeks 1, 2, 8 and 12
RE104 versus placebo percentage of participants with HAM-A response (≥50% reduction in score from Baseline)
Time frame: Weeks 1, 2, 4, 8 and 12
RE104 versus placebo percentage of participants with HAM-A remission (total score ≤7)
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
Time frame: Weeks 1, 2, 4, 8 and 12
RE104 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)
RE104 versus placebo change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) (Part B only)
Time frame: Weeks 1, 2, 4, 8, and 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No. Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.
Related trials for Generalized Anxiety Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Active, not recruitingObservational study
BreathinG-induced Myocardial and Cerebral Perfusion in Anxiety Disorders
Generalized Anxiety Disorder, Oxygenation Sensitive CMR
RecruitingPhase 3
A Study to Asses Safety and Tolerability of ITI-1284 Given Alone or as an Additional Treatment in Participants With Generalized Anxiety Disorder (GAD)
Generalized Anxiety Disorder
RecruitingPhase 3
A Study of JNJ-99245354 (ITI-1284) as an Adjunctive Treatment in Participants With Generalized Anxiety Disorder (GAD) Who Have an Inadequate Response to GAD Treatment
Generalized Anxiety Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mark Pollack, M.D. study director
Reunion Neuroscience Inc
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RE104 for Injection in people with Generalized Anxiety Disorder, run by Reunion Neuroscience Inc at 28 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mark Pollack Chief Medical Officer, M.D. (1-888-880-REUN, info@reunionneuro.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.