RE104 Safety and Efficacy Study in Adjustment Disorder in Cancer and Other Medical Illnesses
This Phase II, randomised, triple-blind, active-dose-controlled trial (n=100) is evaluating RE104 in adults with adjustment disorder related to cancer or another serious medical illness, including ALS, multiple sclerosis, Parkinson’s disease or idiopathic pulmonary fibrosis. Participants receive a single subcutaneous injection of either 30 mg RE104 or a 1.5 mg active-control dose. The trial is designed to determine whether RE104 reduces depressive symptoms, including depressive symptoms mixed with anxiety. The primary outcome compares change from baseline in Montgomery-Åsberg Depression Rating Scale total score between the two dose groups at Day 7, with additional efficacy and safety follow-up.
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Detailed Description
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.
Study Arms & Interventions
RE104 1.5 mg
active comparatorA single subcutaneous injection of 1.5 mg RE104 for Injection
Interventions
- Psilocybin1.5 mgvia Subcutaneous• single dose• 1 doses total
Luvesilocin (RE104); represented under Blossom’s Psilocybin compound record.
RE104 30 mg
experimentalA single subcutaneous injection of 30 mg RE104 for Injection
Interventions
- Psilocybin30 mgvia Subcutaneous• single dose• 1 doses total
Luvesilocin (RE104); represented under Blossom’s Psilocybin compound record.
Participants
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 Protocol, Arms & Participants
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Study Details
- StatusRecruiting
- PhasePhase II
- Typeinterventional
- DesignRandomizedtriple Blind
- Target Enrollment100 participants
- TimelineStart: 2025-07-30End: 2026-12-01
- Compound
- Topic
Study Team
Sponsors & Collaborators
- Reunion NeurosciencePrimary Sponsor
Locations
Recent activity
- StartedRE104 Safety and Efficacy Study in Adjustment Disorder in Cancer and Other Medical Illnesses (NCT07002034, psilocybin)
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