A Randomized, Double-Blind, Parallel-Group, Dose-Controlled Study Evaluating the Safety and Efficacy of RE104 for Injection in the Treatment of Adjustment Disorder in Patients With Cancer and Other Medical Illnesses
Reunion Neuroscience Inc
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.
Eligibility
- Age range
- 18–80 years
- Sex
- All
- 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 pre…
Interventions
- DrugRE104 for Injection
Single, subcutaneous dose of RE104 for Injection
Locations (28)
- UAB, Psychiatry and Behavioral NeurologyBirmingham, Alabama
- University of ArizonaTucson, Arizona
- Kadima Neuropsychiatry InstituteSan Diego, California
- Providence Medical FoundationSanta Rosa, California
- University of ColoradoAurora, Colorado
- University of South Florida, Department of Psychiatry and Behavioral NeuroscienceTampa, Florida