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NCT Number: NCT07002034

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

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.

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Key information

Conditions

Adjustment Disorder Adjustment Disorders Amyotrophic Lateral Sclerosis Anxiety Disorders Autoimmune Diseases Autoimmune Diseases of the Nervous System Behavior Behavioral Symptoms Central Nervous System Diseases Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Depression Idiopathic Pulmonary Fibrosis Immune System Diseases Lung Diseases Lung Diseases, Interstitial Mental Disorders Metabolic Diseases Motor Neuron Disease Multiple Sclerosis Neoplasms Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Pulmonary Fibrosis Respiratory Tract Diseases Spinal Cord Diseases TDP-43 Proteinopathies Trauma and Stressor Related Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UAB, Psychiatry and Behavioral Neurology, Birmingham, Alabama, 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 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

Treatment and study plan

RE104 for Injection

Drug

Single, subcutaneous dose of RE104 for Injection

Primary outcomes

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

    Time frame: Day 7

    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.

Secondary outcomes

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

    Time frame: Day 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.

  2. RE104 30 mg versus RE104 1.5 mg 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 42 days)

    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

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, Parallel-Group, Dose-Controlled Study Evaluating the Safety and Efficacy of RE104 for Injection in the Treatment of Adjustment Disorder in Patients With Cancer and Other Medical Illnesses

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 3, 2025
Registry last updated
Jun 3, 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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