NCT07002034 RE104 Safety and Efficacy Study in Adjustment Disorder in Cancer and Other Medical Illnesses
| NCT ID | NCT07002034 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Reunion Neuroscience Inc |
| Condition | Adjustment Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-07-30 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2025-07-30 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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 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
Contact & Investigator
Mark Pollack, Chief Medical Officer
STUDY DIRECTOR
Reunion Neuroscience Inc
Frequently Asked Questions
Who can join the NCT07002034 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Adjustment Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07002034 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07002034 currently recruiting?
Yes, NCT07002034 is actively recruiting participants. Contact the research team at info@reunionneuro.com for enrollment information.
Where is the NCT07002034 trial being conducted?
This trial is being conducted at Birmingham, United States, Tucson, United States, San Diego, United States, Santa Rosa, United States and 11 additional locations.
Who is sponsoring the NCT07002034 clinical trial?
NCT07002034 is sponsored by Reunion Neuroscience Inc. The principal investigator is Mark Pollack, Chief Medical Officer at Reunion Neuroscience Inc. The trial plans to enroll 100 participants.