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

Phase 2

Not yet recruiting

• Conditions: Adjustment Disorder
• Interventions: Drug: RE104 for Injection

• Registration Number: NCT07002034
• Lead Sponsor: Reunion Neuroscience Inc

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-23
• Study First Submitted QC: 2025-05-23
• Last Update Submitted: 2025-05-23
• Study Start: 2025-06
• Study First Posted: 2025-06-03
• Last Update Posted: 2025-06-03
• Primary Completion: 2026-11
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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, 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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1.5 mg RE104	RE104 for Injection	A single subcutaneous injection of 1.5 mg RE104 for Injection
30 mg RE104	RE104 for Injection	A single subcutaneous injection of 30 mg RE104 for Injection

Primary Outcome Measures

Name	Time	Method
RE104 30 mg versus RE104 1.5 mg change from baseline in MADRS total score	Day 14	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 Outcome Measures

Name	Time	Method
RE104 30 mg versus RE104 1.5 mg changes in total score from baseline in Hamilton Anxiety Rating Scale (HAM-A)	Day 14	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.
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)	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.