ATAI ELUMINA STUDY FOR TREATMENT RESISTANT DEPRESSION

This is a 5-month study of an investigational psychedelic medication to determine the efficacy, safety and tolerability in participants with treatment resistant depression (TRD). Participants may be eligible if they are 18-65 years of age and experiencing symptoms of treatment-resistant depression. Individuals with a co-morbid diagnosis or past history of the following are not eligible to participate – PTSD, OCD, Bipolar disorder, Schizophrenia, Schizoaffective disorder, or Borderline Personality Disorder.   Administered under supportive conditions to adult participants with treatment resistant depression. 

• PI – Daniel Fallon, MD
• Study Coordinators
  Dakota Helgager   (813) 954-3945 | dakotahelgager@usf.edu 
  Genesis Estremera  (813) 440-9452 | gestremera@usf.edu 

KOASTAL – MAJOR DEPRESSION WITH ANHEDONIA 

This is a two-month double-blind placebo controlled study followed by a 54-week open-label study to evaluate the efficacy and safety of NMRA-335140 in adults 18-65 years of age with Major Depression. To be eligible participants will be depressed for 1-12 months.  

• PI – Ram Bishnoi, MD
• Study Coordinator 
  Angela McDowell, RN (813) 440-9438 | angelamcdowell@usf.edu 

TRANSCEND – DEEP BRAIN STIMULATION FOR TREATMENT RESISTANT  DEPRESSION

This is a 3-year study to determine the effectiveness and safety of Deep Brain Stimulation (DBS) in people with Treatment-Resistant Depression.  To be eligible participants must have failed 2-4 antidepressant medications during the current episode of depression and be 22-70 years of age.  Subjects must be good surgery candidates.  

• PI – Ryan Wagoner, MD
• Study Coordinator
  Angela McDowell, RN (813) 440-9438 | angelamcdowell@usf.edu 

REUNION ADCO – ADJUSTMENT DISORDER ASSOCIATED WITH MEDICAL ILLNESS

This is a 42-day study to determine the effectiveness and safety of an investigational psychedelic medication in the treatment of Adjustment Disorder associated with medical illnesses (Cancer, ALS, MS, PD, or IPF).  To be eligible participants must be 18-80 years old, have a greater than/equal to a 4 week history of adjustment disorder.  Eligible subjects will also have a life expectancy of at least 6 months.  Other criteria apply.    

• PI – Daniel Fallon, MD
• Study Coordinator
  Katrina Ostrovsky (813) 493-4932926 | katrinaostrovsky@usf.edu 

MILD TO SEVERE ALZHEIMER’S DISEASE WITH AGITATION

This is an 8 week study to evaluate an investigational drug containing THC and melatonin compared to placebo in individuals with mild to severe Alzheimer’s disease with agitation symptoms.  Participants will have a diagnosis of Alzheimer’s disease, have agitation, and have a caregiver willing to participate in the study.  There is a planned open-label extension study. 

• PI – Ram Bishnoi, MD
• Study Coordinators:
  Ezra Hussain - (813) 492-5946 | ezrahussain@usf.edu 
  Julianna Moura - (813) 440-9440 | juliannamoura@usf.edu

ALZHEIMER’S DISEASE WITH PSYCHOSIS

A 12-week study to evaluate safety and efficacy of ITI-1284, an investigational drug, in patients with Alzheimer’s disease with psychosis.  Eligible patients will be > 55 years of age, have a diagnosis of Alzheimer’s disease, experiencing symptoms of psychosis, and have a partner or caregiver to attend study visits. 

• PI – Ram Bishnoi, MD
• Study Coordinators:
  Angela McDowell, RN - (813) 440-9438 | angelamcdowell@usf.edu
  Ezra Hussain - (813) 493-5946 | ezrahussain@usf.edu

Healthy Volunteer Trials
PRE-CLINICIAL ALZHEIMER’S DISEASE 

This study is divided into two parts: Screening and Treatment.  During the Screening period – up to 125 individuals ages 65-80 years will undergo a standard memory evaluation including plasma (blood biomarkers) p-tau levels.  This is ideal for individuals who are not experiencing memory/cognitive systems but have a family history of Alzheimer’s disease. Individuals with AD biomarkers will go on to have an MRI and a PET scan.  Subjects with imaging biomarkers will be invited to continue into the treatment phase of the study.  The treatment phase involves an investigational vaccine to determine if the vaccine prevents development or progression of AD.  It is expected that only 10 individuals will progress to the vaccine phase of the study (of the 125 individuals screened). 

•  PI – Daniel Fallon, MD
•  Study Coordinators 
   Randa Abdulkarim – (656) 244-6936
   Genesis Estremera  (813) 440-9452 | gestremera@usf.edu 

Please check back soon for future studies.

Please check back soon for future studies.

Please check back soon for future studies.

REUNION GENERALIZED ANXIETY DISORDER – Psychedelic Treatment Study – Opening in April 2026

This study will evaluate the safety and efficacy of a single-dose injection of RE104 30mg compared to placebo in individuals with Generalized Anxiety Disorder.  The study has a 21-day screening period, a one-day treatment period, and an 84-day Follow-up period.  To be eligible – must be 18-74 years of age inclusive, have GAD which is primary focus of treatment, and have a HAM-A score of at least 20 (HAM-A will be done at screening).  Current or past diagnoses of PTSD, Bipolar, Borderline Personality disorder, Schizophrenia, Schizoaffective disorder, or a Psychotic disorder are exclusionary for the study. 

Other criteria apply.  Interested patients can be placed on call list now for this study.  It will enroll very fast!  

• PI – Daniel Fallon, MD
• Study Coordinator
  Genesis Estremera (813) 440-9452 | gestremera@usf.edu 

ITI – GENERALIZED ANXIETY DISORDER – Opening in January 2026

This is a 6-week study to evaluate two doses of ITI-1284, an investigational drug, to placebo as monotherapy for individuals with primary Generalized Anxiety Disorder.  Participants will have a diagnosis of Generalized Anxiety Disorder and have had an inadequate response to at least one of the following paroxetine, venlafaxine XR, duloxetine, escitalopram, or buspirone.   

• PI – Daniel Fallon, MD
• Study Coordinator
  Tabytha Demir (813) 493- 6026 | tmichel10@usf.edu 

Coming Soon:

Post-Traumatic Stress Disorder- Psilocybin study (check back in March 2026)