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

Reunion Neuroscience

Status and phase: Enrolling; Phase 2

Conditions: Adjustment Disorder

Treatments: Drug: RE104 for Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07002034

RE104-202-ADCO

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

1.5 mg RE104

Active Comparator group

Description:

A single subcutaneous injection of 1.5 mg RE104 for Injection

Treatment:

Drug: RE104 for Injection

30 mg RE104

Experimental group

Description:

A single subcutaneous injection of 30 mg RE104 for Injection

Treatment:

Drug: RE104 for Injection