RE104 Safety and Efficacy Study in Adjustment Disorder in Cancer and Other Medical Illnesses
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.
Condition
- Adjustment Disorder
Eligibility
- Eligible Ages
- Between 18 Years and 80 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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 |
|
Recruiting Locations
UAB, Psychiatry and Behavioral Neurology
Birmingham 4049979, Alabama 4829764 35209
Birmingham 4049979, Alabama 4829764 35209
More Details
- Status
- Recruiting
- Sponsor
- Reunion Neuroscience Inc