Recruiting

Phase 2

RE104RE104 Safety and Efficacy Study in Adjustment Disorder in Cancer and Other Medical Illnesses

Sponsor:

Reunion Neuroscience Inc

Code:

NCT07002034

Conditions

Adjustment Disorder

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

RE104 for Injection

Study Details

Brief summary:

The purpose of this study is to determine if treatment with a single dose of RE104 for Injection reduces depressive symptoms or depressive symptoms mixed with anxiety symptoms in participants with Adjustment Disorder due to cancer or other illnesses such as Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Parkinson's Disease (PD) or Idiopathic Pulmonary Fibrosis (IPF) as compared to active-placebo.

Conditions

Adjustment Disorder

Study ID

NCT07002034

Start date

Jul 30, 2025

Status verified date

Aug, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Has a ≥4 week history of AjD as defined by DSM-5-TR with either depressed mood, or mixed anxiety and depressed mood confirmed by clinical interview with evidence that the AjD was instigated by one of the following medical illnesses (e.g., diagnosis, impact, management, recurrence, prognosis): Cancer, ALS, MS, PD or IPF
Is sufficiently ambulatory and capable of self care as necessary to complete study procedures
Has normal cognitive function
Is on stable use of antidepressants or psychotherapy, or is willing to delay use until the end of study
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 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 active or a history of central nervous system malignancy
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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 1.5 mg RE104

A single subcutaneous injection of 1.5 mg RE104 for Injection

experimental: 30 mg RE104

A single subcutaneous injection of 30 mg RE104 for Injection

Interventions

RE104 for Injection

Single, subcutaneous dose of RE104 for Injection

Primary outcome measure

RE104 30 mg versus RE104 1.5 mg change from baseline in MADRS total score [ Time Frame: Day 7 ]

Central Contacts and Locations

Central contacts

Mark Pollack, Chief Medical Officer

1-888-880-REUN info@reunionneuro.com

Locations

UAB, Psychiatry and Behavioral Neurology

Recruiting

Birmingham, Alabama, United States, 35209

Contacts

Seher Premani

205-996-1198 spremani@uab.edu

University of Arizona

Recruiting

Tucson, Arizona, United States, 85724

Contacts

Esmeralda Terrazas

(520) 626-4804 esmeralda97h@arizona.edu

Kadima Neuropsychiatry Institute

Recruiting

San Diego, California, United States, 92037

Contacts

Angelica Lau

858-775-2053 angelical@kadimanp.com

Providence Medical Foundation

Recruiting

Santa Rosa, California, United States, 95403

Contacts

Melissa Ulrich

Melissa.Ulrich@providence.org

University of Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Mary Mancuso

MARY.MANCUSO@CUANSCHUTZ.EDU

University of South Florida, Department of Psychiatry and Behavioral Neuroscience

Recruiting

Tampa, Florida, United States, 33613

Contacts

Yvonne Bannon

813-974-2832 ybannon@usf.edu

Emory University

Recruiting

Atlanta, Georgia, United States, 30329

Contacts

Kaila Flemming-Peruza

404-778-6663 kaila.flemming-peruza@emory.edu

Hawaii Pacific Neuroscience

Recruiting

Honolulu, Hawaii, United States, 96817

Contacts

Peter Nguyen

pnguyen@hawaiineuroscience.com

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Linda Skaggs

Linda_Skaggs@rush.edu

University of Chicago Medical Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Ana Delariva

773-795-2378 Ana.Delariva@bsd.uchicago.edu

The University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Travis Martin

tmartin5@kumc.edu

LSU Health Shreveport

Recruiting

Shreveport, Louisiana, United States, 71103

Contacts

Chelsie Liegey

318-675-7064 chelsie.liegey@lsuhs.edu

Sunstone Therapies, PC

Recruiting

Rockville, Maryland, United States, 20850

Contacts

Reunion Investigational Site

info@reunionneuro.com

Sheppard Pratt

Recruiting

Towson, Maryland, United States, 21204

Contacts

Jeff LaPratt

Jeffrey.LaPratt@sheppardpratt.org

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Gabriel Najarian

gabriel_najarian@dfci.harvard.edu

University of Massachusetts Chan Medical Center

Recruiting

Worcester, Massachusetts, United States, 01655

Contacts

Michelangela Yusif

774-455-4136 Michelangela.Yusif@umassmed.edu

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

OCTSU Team

RE104_researchermm@med.umich.edu

Henry Ford Health

Recruiting

Novi, Michigan, United States, 48377

Contacts

Michaela Mogle

mmogle1@hfhs.org

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Contacts

Kelsey Noble

kenoble@unmc.edu

University of New Mexico, School of Medicine

Recruiting

Albuquerque, New Mexico, United States, 87131

Contacts

Hector Garcia

hecgarcia@salud.unm.edu

Roswell Park Center Institute

Recruiting

Buffalo, New York, United States, 14263

Contacts

William Alexander

716-845-1300 William.Alexander@RoswellPark.org

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Contacts

Kahini Patel

kahini.patel@nyulangone.org

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

Rachel Grace Kozik

rachel_kozik@med.unc.edu

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44113

Contacts

Katelyn Schwesinger

216-425-7426 psychresearch@ccf.org

The Ohio State University, Department of Psychiatry

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Anne-Marie Duchemin

anne-marie.duchemin@osumc.edu

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Erin Blase

215-746-6419 erin.blase@pennmedicine.upenn.edu

Alliance for Multispecialty Research Clinical

Recruiting

Knoxville, Tennessee, United States, 37920

Contacts

Amy Rushing

865-659-0406 amy.rushing@amr-clinical.com

Dell Medical School, University of Texas at Austin

Recruiting

Austin, Texas, United States, 78712

Contacts

Kelly Jackson

561-777-5684 kelly.jackson@austin.utexas.edu

Cedar Clinical Research Inc.

Recruiting

Draper, Utah, United States, 84020

Contacts

Kye Cutrubus

kye.cutrubus@numinusnetwork.com

UVA Center for Psychiatric Clinical Research

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Fatima Nayani

fzn3aa@uvahealth.org

Seattle Neuropsychiatric Treatment Center

Recruiting

Seattle, Washington, United States, 98104

Contacts

Libby Kell

Reunion.Rekindle@seattlentc.com

University of Wisconsin at Madison

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Zachary Stowe

zstowe@wisc.edu

More Information

Sponsor

Reunion Neuroscience Inc

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Keywords

Cancer
Amyotrophic Lateral Sclerosis (ALS)
Multiple Sclerosis (MS)
Parkinson&#39;s Disease (PD)
Idiopathic Pulmonary Fibrosis (IPF)
Depression
Anxiety
Psychiatric Distress

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Reunion Neuroscience Inc on 2026-08-24.