Single-dose RE104 injection for adjustment disorder in people with cancer or certain chronic illnesses

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional trial gives eligible participants a single dose of RE104 for Injection and compares symptom change to an active placebo. Participants must have at least a four-week history of adjustment disorder with depressed mood or mixed anxiety and depression triggered by a qualifying medical illness and must be ambulatory with normal cognition. Concomitant antidepressants or psychotherapy are allowed if stable, or can be delayed until study end, and people with high suicide risk or primary psychotic or bipolar disorders are excluded. Recruitment occurs at three U.S. sites and standardized clinical rating scales will be used to measure changes in depressive and anxiety symptoms.

Why it matters

Who can join: the full rules

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 a history of current active 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

Where it's running

• UAB, Psychiatry and Behavioral Neurology
  Birmingham, Alabama, United States Recruiting
• University of Arizona
  Tucson, Arizona, United States Recruiting
• Kadima Neuropsychiatry Institute
  San Diego, California, United States Recruiting
• University of Colorado
  Aurora, Colorado, United States Recruiting
• University of South Florida, Department of Psychiatry and Behavioral Neuroscience
  Tampa, Florida, United States Recruiting
• Emory University
  Atlanta, Georgia, United States Recruiting

Study contacts

• Study coordinator: Mark Pollack, Chief Medical Officer
• Email: info@reunionneuro.com
• Phone: 1-888-880-REUN

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.