COMP006 - COMP360 (PSILOCYBIN) FOR TREATMENT RESISTANT DEPRESSION

This is a placebo controlled 12-week study to investigate the efficacy, safety, and tolerability of COMP360 (psilocybin) in participants with treatment resistant depression (TRD). Administered under supportive conditions to adult participants with treatment resistant depression.

PI – Ryan Wagoner, MD

Study Coordinator – Andrea Mockabee (813) 440-9444 | amockabee@usf.edu

NMRA 302 -  DEPRESSION

This is a 16-week study to evaluate the effects of NMRA-335140, a selective kappa-opioid receptor antagonist, versus placebo in participants with major depressive disorder. Participants meeting criteria may continue study drug in an open label extension study.

PI – Ram Bishnoi, MD

Study Coordinator – Angela McDowell, RN (813) 440-9438 | angelamcdowell@usf.edu

DEPRESSION WITH INSOMNIA

A 6-week placebo-controlled study to evaluate efficacy and safety and the maintenance of effect of 20-mg Seltorexant as adjunctive therapy to SSRI/SNRI antidepressants in adult and elderly patients with MDD with Insomnia Symptoms.

PI – Ram Bishnoi, MD

Study Coordinator – Beverly Harrell, LPN (813) 440-9428 | hmb2@usf.edu

DBS FOR TREATMENT RESISTANT DEPRESSION

This study is designed as a prospective, multi-centered, double-blind, randomized, controlled 12-month study to evaluate the safety and effectiveness of deep brain stimulation as an investigational therapy to treat TRD using the Infinity™ DBS System.

PI – Ryan Wagoner, MD

Recruiter - Angela McDowell, RN (813) 440-9438 | angelamcdowell@usf.edu

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.  Study medication is administered under supportive conditions to adult participants with treatment resistant depression.

PI – Daniel Fallon, MD

Study Coordinators:

Ezra Hussain - (813) 493-5946 | ezrahussain@usf.edu

Julianna Moura - (813) 440-9440 | juliannamoura@usf.edu

Mariah Nelson - (813) 440-9428 | Mariahn@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 Coordinators:

Katrina Ostrovsky - (813) 493-2926 | katrinaostrovsky@usf.edu 

Mariah Nelson, RN - (813) 440-9428 | mariahn@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

Please check back soon for future studies.

ADHD in CHILDREN 4-5 YEARS

This is a 35-day fixed-dose double-blind, placebo-controlled study to evaluate the safety and pharmacokinetic of evening dosed Methylphenidate Hydrochloride Extended-Release (HLD200) in children aged 4-5 years with Attention Deficit Hyperactivity Disorder.   

PI – Daniel Fallon, MD

Study Coordinators:

Ezra Hussain - (813) 493-5946 | ezrahussain@usf.edu

Tabytha Michel - (813) 493-6026 | tmichel10@usf.edu

Please check back soon for future studies.