RE104 Safety and Efficacy Study in Adjustment Disorder in Cancer and Other Medical Illnesses

NCT ID: NCT07002034

Last Updated: 2025-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-30

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Adjustment Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1.5 mg RE104

A single subcutaneous injection of 1.5 mg RE104 for Injection

Group Type ACTIVE_COMPARATOR

RE104 for Injection

Intervention Type DRUG

Single, subcutaneous dose of RE104 for Injection

30 mg RE104

A single subcutaneous injection of 30 mg RE104 for Injection

Group Type EXPERIMENTAL

RE104 for Injection

Intervention Type DRUG

Single, subcutaneous dose of RE104 for Injection

Interventions

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RE104 for Injection

Single, subcutaneous dose of RE104 for Injection

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Reunion Neuroscience Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark Pollack, Chief Medical Officer

Role: STUDY_DIRECTOR

Reunion Neuroscience Inc

Locations

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UAB, Psychiatry and Behavioral Neurology

Birmingham, Alabama, United States

Site Status RECRUITING

University of Arizona

Tucson, Arizona, United States

Site Status RECRUITING

Kadima Neuropsychiatry Institute

San Diego, California, United States

Site Status RECRUITING

Providence Medical Foundation

Santa Rosa, California, United States

Site Status RECRUITING

University of Colorado

Aurora, Colorado, United States

Site Status RECRUITING

University of South Florida, Department of Psychiatry and Behavioral Neuroscience

Tampa, Florida, United States

Site Status RECRUITING

Hawaii Pacific Neuroscience

Honolulu, Hawaii, United States

Site Status RECRUITING

LSU Health Shreveport

Shreveport, Louisiana, United States

Site Status RECRUITING

Sunstone Therapies, PC

Rockville, Maryland, United States

Site Status RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status RECRUITING

Henry Ford Health

Novi, Michigan, United States

Site Status RECRUITING

University of New Mexico, School of Medicine

Albuquerque, New Mexico, United States

Site Status RECRUITING

NYU Langone Center for Psychedelic Medicine

New York, New York, United States

Site Status RECRUITING

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status RECRUITING

The Ohio State University, Department of Psychiatry

Columbus, Ohio, United States

Site Status RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Dell Medical School, University of Texas at Austin

Austin, Texas, United States

Site Status RECRUITING

Cedar Clinical Research Inc.

Draper, Utah, United States

Site Status RECRUITING

UVA Center for Psychiatric Clinical Research

Charlottesville, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Mark Pollack, Chief Medical Officer

Role: CONTACT

1-888-880-REUN

Facility Contacts

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Seher Premani

Role: primary

205-996-1198

Esmeralda Terrazas

Role: primary

(520) 626-4804

Angelica Lau

Role: primary

858-775-2053

Melissa Ulrich

Role: primary

Mary Mancuso

Role: primary

Yvonne Bannon

Role: primary

813-974-2832

Peter Nguyen

Role: primary

Chelsie Liegey

Role: primary

318-675-7064

Reunion Investigational Site

Role: primary

Gabriel Najarian

Role: primary

Atena Gutierrrez

Role: primary

Hector Garcia

Role: primary

Jessica Hawkins

Role: primary

Rachel Grace Kozik

Role: primary

Anne-Marie Duchemin

Role: primary

Erin Blase

Role: primary

215-746-6419

Kelly Jackson

Role: primary

561-777-5684

Janet Jimenez

Role: primary

Fatima Nayani

Role: primary

Other Identifiers

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RE104-202-ADCO

Identifier Type: -

Identifier Source: org_study_id

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