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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 80 Years
Gender	All

More Inclusion & Exclusion Criteria

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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07002034
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Reunion Neuroscience Inc
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Mark Pollack, Chief Medical Officer
Principal Investigator Affiliation	Reunion Neuroscience Inc
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Adjustment Disorder

Arms & Interventions

Arms

Active Comparator: 1.5 mg RE104

A single subcutaneous injection of 1.5 mg RE104 for Injection

Experimental: 30 mg RE104

A single subcutaneous injection of 30 mg RE104 for Injection

Interventions

Drug: - RE104 for Injection

Single, subcutaneous dose of RE104 for Injection

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

UAB, Psychiatry and Behavioral Neurology, Birmingham 4049979, Alabama 4829764

Status

Recruiting

Address

UAB, Psychiatry and Behavioral Neurology

Birmingham 4049979, Alabama 4829764, 35209

Site Contact

Seher Premani

[email protected]

205-996-1198

Tampa 4174757, Florida 4155751

Status