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
University of Arizona
Tucson 5318313, Arizona 5551752 85724
Tucson 5318313, Arizona 5551752 85724
Kadima Neuropsychiatry Institute
San Diego 5391811, California 5332921 92037
San Diego 5391811, California 5332921 92037
Providence Medical Foundation
Santa Rosa 5393287, California 5332921 95403
Santa Rosa 5393287, California 5332921 95403
University of Colorado
Aurora 5412347, Colorado 5417618 80045
Aurora 5412347, Colorado 5417618 80045
University of South Florida, Department of Psychiatry and Behavioral Neuroscience
Tampa 4174757, Florida 4155751 33613
Tampa 4174757, Florida 4155751 33613
Emory University
Atlanta 4180439, Georgia 4197000 30329
Atlanta 4180439, Georgia 4197000 30329
Hawaii Pacific Neuroscience
Honolulu 5856195, Hawaii 5855797 96817
Honolulu 5856195, Hawaii 5855797 96817
Rush University Medical Center
Chicago 4887398, Illinois 4896861 60612
Chicago 4887398, Illinois 4896861 60612
LSU Health Shreveport
Shreveport 4341513, Louisiana 4331987 71103
Shreveport 4341513, Louisiana 4331987 71103
Sunstone Therapies, PC
Rockville 4367175, Maryland 4361885 20850
Rockville 4367175, Maryland 4361885 20850
Dana Farber Cancer Institute
Boston 4930956, Massachusetts 6254926 02215
Boston 4930956, Massachusetts 6254926 02215
University of New Mexico, School of Medicine
Albuquerque 5454711, New Mexico 5481136 87131
Albuquerque 5454711, New Mexico 5481136 87131
NYU Langone Center for Psychedelic Medicine
New York 5128581, New York 5128638 10016
New York 5128581, New York 5128638 10016
University of North Carolina at Chapel Hill
Chapel Hill 4460162, North Carolina 4482348 27514
Chapel Hill 4460162, North Carolina 4482348 27514
The Ohio State University, Department of Psychiatry
Columbus 4509177, Ohio 5165418 43210
Columbus 4509177, Ohio 5165418 43210
University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927 19104
Philadelphia 4560349, Pennsylvania 6254927 19104
Alliance for Multispecialty Research Clinical
Knoxville 4634946, Tennessee 4662168 37920
Knoxville 4634946, Tennessee 4662168 37920
Dell Medical School, University of Texas at Austin
Austin 4671654, Texas 4736286 78712
Austin 4671654, Texas 4736286 78712
Cedar Clinical Research Inc.
Draper 5774001, Utah 5549030 84020
Draper 5774001, Utah 5549030 84020
UVA Center for Psychiatric Clinical Research
Charlottesville 4752031, Virginia 6254928 22903
Charlottesville 4752031, Virginia 6254928 22903
More Details
- NCT ID
- NCT07002034
- Status
- Recruiting
- Sponsor
- Reunion Neuroscience Inc