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

NCT07002034 | Recruiting Phase 2 FDA Drug

• 1 other identifier: RE104-202-ADCO
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 28

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• RE104 30 mg versus RE104 1.5 mg change from baseline in MADRS total score

  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.

  Day 7

Secondary Outcomes (2)

• RE104 30 mg versus RE104 1.5 mg changes in total score from baseline in Hamilton Anxiety Rating Scale (HAM-A)

  Day 7

• RE104 30 mg versus RE104 1.5 mg incidence of treatment-emergent adverse events (TEAEs) by frequency, severity and seriousness.

  From dosing through study completion (post-dose follow-up is for 42 days)

Study Arms (2)

1.5 mg RE104

ACTIVE COMPARATOR

A single subcutaneous injection of 1.5 mg RE104 for Injection

Drug: RE104 for Injection

30 mg RE104

EXPERIMENTAL

A single subcutaneous injection of 30 mg RE104 for Injection

Drug: RE104 for Injection

Interventions

RE104 for Injection DRUG

Single, subcutaneous dose of RE104 for Injection

1.5 mg RE104; 30 mg RE104

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Reunion Neuroscience Inc: lead

Study Sites (28)

UAB, Psychiatry and Behavioral Neurology

Birmingham, Alabama, 35209, United States

RECRUITING

University of Arizona

Tucson, Arizona, 85724, United States

RECRUITING

Kadima Neuropsychiatry Institute

San Diego, California, 92037, United States

RECRUITING

Providence Medical Foundation

Santa Rosa, California, 95403, United States

RECRUITING

University of Colorado

Aurora, Colorado, 80045, United States

RECRUITING

University of South Florida, Department of Psychiatry and Behavioral Neuroscience

Tampa, Florida, 33613, United States

RECRUITING

Emory University

Atlanta, Georgia, 30329, United States

RECRUITING

Hawaii Pacific Neuroscience

Honolulu, Hawaii, 96817, United States

RECRUITING

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

The University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

LSU Health Shreveport

Shreveport, Louisiana, 71103, United States

RECRUITING

Sunstone Therapies, PC

Rockville, Maryland, 20850, United States

RECRUITING

Sheppard Pratt

Towson, Maryland, 21204, United States

RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Henry Ford Health

Novi, Michigan, 48377, United States

RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

RECRUITING

University of New Mexico, School of Medicine

Albuquerque, New Mexico, 87131, United States

RECRUITING

NYU Langone Center for Psychedelic Medicine

New York, New York, 10016, United States

RECRUITING

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44113, United States

RECRUITING

The Ohio State University, Department of Psychiatry

Columbus, Ohio, 43210, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Alliance for Multispecialty Research Clinical

Knoxville, Tennessee, 37920, United States

RECRUITING

Dell Medical School, University of Texas at Austin

Austin, Texas, 78712, United States

RECRUITING

Cedar Clinical Research Inc.

Draper, Utah, 84020, United States

RECRUITING

UVA Center for Psychiatric Clinical Research

Charlottesville, Virginia, 22903, United States

RECRUITING

Seattle Neuropsychiatric Treatment Center

Seattle, Washington, 98104, United States

RECRUITING

MeSH Terms

Conditions

Adjustment Disorders; Neoplasms; Amyotrophic Lateral Sclerosis; Multiple Sclerosis; Idiopathic Pulmonary Fibrosis; Depression; Anxiety Disorders

Interventions

Injections

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders; Mental Disorders; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Mark Pollack, Chief Medical Officer

  Reunion Neuroscience Inc

  STUDY DIRECTOR

Central Study Contacts

Mark Pollack, Chief Medical Officer

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: June 3, 2025
• Study Start: July 30, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (28)