ESKETAMINE FOR TREATMENT RESISTANT DEPRESSION

This is a 10-week study to evaluate the effectiveness esketamine nasal spray.  Eligible patients will have a diagnosis of major depression and have had an inadequate response to antidepressants during the current episode. Subjects must be 18 years of age and older and medically stable. There is an open label extension to this study (up to 3 months).

PI: Glenn Currier, MD, MPH

Study Coordinator: Julie Samson - (813) 440-9428 | jsamson@usf.edu

Back-up SC: Ahsan Qadir - (813) 440-9440 | aqadir@usf.edu

DEPRESSION WITH INSOMNIA

A 24-week study to assess the effectiveness and safety of 20 mg seltorexant versus standard of care quetiapine XR 150 or 300 mg as add-on treatment to an antidepressant medication (either an SSRI or SNRI) in adults ages 18 – 74 with Depression with insomnia symptoms who have had inadequate response to 1-2 antidepressants in the current episode.

PI: Glenn Currier, MD, MPH

Study Coordinator: Kathy Smith - (813) 440-9414 | kathryns@usf.edu

Back-up SC: Cristal Ruiz - (813) 440-9434 | ruizc@usf.edu

MK-1942 FOR TREATMENT RESISTANT DEPRESSION

This is a 6-week study to evaluate the effectiveness and safety of an investigational medication, MK-1942, as add on treatment to stable antidepressant therapy for treatment-resistant depression. 

PI: Glenn Currier, MD, MPH

Study Coordinator: Cristal Ruiz, RN - (813) 440-9434 | ruizc@usf.edu 

Back-up SC: Sophia Wiltse - (813) 440-9438 | swiltse@usf.edu

OTSUKA 062 DEPRESSION

This is an 11-week study to investigate the effectiveness, safety and tolerability of Centanafadine XR in adults 18-65 years with Depression who have an inadequate response to at least 1 but no more than 3 medications treatments for depression in their current major depressive episode.

PI: Glenn Currier, MD, MPH

Study Coordinator: Ahsan Qadir - (813) 440-9440 | aqadir@usf.edu

Back-up SC- Cristal Ruiz - (813) 440-9434 | ruizc@usf.edu

COMP360 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 adults participants with treatment resistant depression.

PI: Glenn Currier, MD, MPH

Study Coordinator: Robert Doran - (813) 440-9452 | doran117@usf.edu

Back-up SC: Cristal Ruiz - (813) 440-9434 | ruizc@usf.edu

DEEP BRAIN STIMULATION FOR ALZHEIMER’S DISEASE

A 48-month study to evaluate the safety and effectiveness of Deep Brain Stimulation in patients with mild probable Alzheimer’s disease. Eligible patients will be 65 years of age or older, in good general health, have a diagnosis of mild Alzheimer’s disease, have a partner or caregiver to accompany to study visits, and be currently taking medication for Alzheimer’s disease OR have a known intolerance to an Alzheimer’s disease medication.

PI: Jean Fils, MD

Study Coordinator: Julie Samson – (813) 440-9428 | jsamson@usf.edu

Back-up SC: Sophia Wiltse - (813) 440-9438 | swiltse@usf.edu

ALZHEIMER’S WITH AGITATION

This is a 20 week study to assess effectiveness, safety, and tolerability of deudetromethorphan hydrobromide /quinidine sulfate for the treatment of agitation related to Alzheimer’s disease in patients 50 – 90 years of age. 

PI: Jean Fils, MD

Study Coordinator: Sophia Wiltse - (813) 440-9438 | swiltse@usf.edu

Back-up SC: Cristal Ruiz - (813)440-9434 | ruizc@usf.edu

MILD DEMENTIA DUE TO ALZHEIMER’S DISEASE

This 28-week study will assess an investigational medication’s, piromelatine, safety and effectiveness in people with mild dementia due to Alzheimer’s disease. Eligible patients will be 60-85 years of age, in good general health, have a diagnosis of Alzheimer’s disease, and have a partner or caregiver to accompany to study visits.

PI: Jean Fils, MD

Study Coordinator: Robert Doran - (813) 440-9452 | doran117@usf.edu

Back-up SC: Julie Samson – (813) 440-9428 | jsamson@usf.edu

ALZHEIMER’S DISEASE VACCINE STUDY

A 28-week study to evaluate safety and efficacy of vaccine, AV-1959D, in patients with Mild Cognitive Impairment, Alzheimer’s type or early onset Alzheimer’s disease. Eligible patients will be 60 to 85 years of age, in good general health, have a diagnosis of Alzheimer’s disease, and have a partner or caregiver to accompany to study visits.

PI: Jean Fils, MD

Study Coordinator: Sophia Wiltse - (813) 440-9438 | swiltse@usf.edu

IRRITABILITY IN AUTISM SPECTRUM DISORDER - ADOLESCENTS

An 8-week study to assess the efficacy, safety, and tolerability of an investigational medication, AB-2004, in adolescents ages 13 - 17 year-old with Autism Spectrum Disorder.  This investigational works in the gut (stomach) to pull out certain bacteria.  It is thought that certain bacteria in the stomach may cause characteristics, such as irritability, in autism.  AB-2004 is designed to adsorb these substances to reduce their levels circulating in the blood stream.

PI: Daniel Fallon, MD

Study Coordinator: Julie Samson – (813) 440-9428 | jsamson@usf.edu

Back-up SC: Sophia Wiltse - (813) 440-9438 | swiltse@usf.edu

AUTISM SPECTRUM DISORDER AGES 12-45 YEARS - SOCIAL COMMUNICATION AND IRRITABILITY STUDY

This is a 25-week study to investigate the efficacy, safety and tolerability of an investigational medication, ML-004 – Zolmitriptan – US Brand name Zomig) in adolescents and adults with autism spectrum disorders (ASD) for improvement of social communication, social deficits, and irritability symptoms associated with Autism Spectrum Disorder. 

PI: Daniel Fallon, MD

Study Coordinator: Ahsan Qadir - (813) 440-9440 | aqadir@usf.edu

Back-up SC: Julie Samson – (813) 440-9428 | jsamson@usf.edu

ADHD STUDY- CHILD STUDY

This is a 6-week study to determine the safety and tolerability of Centanafadine extended release (XR) in ADHD in children ages 4-12 years.  Child must have a primary diagnosis of ADHD. There is an open label extension to this study (up to 34 months).

PI: Daniel Fallon, MD

Study Coordinator: Sophia Wiltse - (813) 440-9438 | swiltse@usf.edu

Back-up SC: Cristal Ruiz, RN - (813) 440-9434 | ruizc@usf.edu

CARIPRAZINE FOR TREATMENT OF BIOPOLAR I, DEPRESSION IN 10-17 YEAR OLDS

This is a 6-week study to evaluate the effectiveness and safety of Cariprazine versus placebo in children and adolescents age 10-17 years who are currently experiencing a depressive episode.

PI: Daniel Fallon, MD

Study Coordinator: Cristal Ruiz, RN - (813) 440-9434 | ruizc@usf.edu

Back-up SC: Julie Samson - (813) 440-9428 | jsamson@usf.edu