Clinical Trials

Current Trials Open to Enrollment

The Department of Psychiatry and Behavioral Neurosciences is currently conducting several clinical trials. We would like to open enrollment to patients in your practice. Please contact the study coordinator or the recruitment line at 813-974-1404

Adult Trials:

OBSERVATIONAL STUDY IN INTERMITTENT EXPLOSIVE DISORDER

Study duration is three months, comprised of three study visits which may be conducted in person or virtually. This is a non-interventional natural history and validation study to determine the manifestation/presentation of IED over a 12-week time frame. Eligible subjects will be 18 years of age and older with a current diagnosis of IED, and must be willing and able to complete a daily log and three site visits in which they will be administered questionnaires.

PI – Glenn Currier, MD, MPH; Study Coordinator – Cristal Ruiz – 813-974-2985.

BIPOLAR I – MANIC, DEPRESSIVE, WITH OR WITHOUT MIXED FEATURES

A 60-week study of the safety and efficacy of cariprazine in the prevention of relapse in patients with Bipolar I disorder. Eligible patients will be between 18 and 65 years of age and in good general health, and have a diagnosis of Bipolar I with current episode manic or depressive, with or without mixed features.

PI – Jean Fils, MD; Study Coordinator – Julie Samson – 813-974-1201.

DEEP BRAIN STIMULATION FOR ALZHEIMER’S DISEASE

A 48-month, double-blind, randomized, controlled study to evaluate the safety and efficacy 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 – 813-974-1201.

MDD - CARIPRAZINE AS ADJUNCT TO CURRENT ADT

A 6-week study to evaluate the safety, tolerability and efficacy of cariprazine 1.5 mg/day and 3 mg/day compared with placebo as an adjunctive to current antidepressant therapy in patients with major depressive disorder who have had an inadequate response to antidepressants alone. Eligible patients will be 18 - 65 years of age and in good general health.

PI – Glenn Currier, MD, MPH; Study Coordinator – Cristal Ruiz – 813-974-2985.

Upcoming Trials:

ESKETAMINE FOR TREATMENT RESISTANT DEPRESSION

A 6-week study to evaluate the efficacy of 56 mg and 84 mg doses of esketamine nasal spray compared with placebo. Eligible patients will have a diagnosis of single-episode MDD or recurrent MDD without psychotic features and have had nonresponse to > 2 oral antidepressants in 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 – Cristal Ruiz – 813-974-2985.