Clinical Trials

Current Trials Open to Enrollment

Adult Trials:

TREATMENT-RESISTANT DEPRESSION

A 12-week outcome comparator study of three standard of care treatments for Treatment-Resistant Depression. Individuals ages 18-80 may be eligible to participate. Participants randomized to one of three standard of care treatments: Antidepressant with Aripiprazole add-on; Antidepressant with TMS; and switch from current Antidepressant to duloxetine or venlafaxine extended-release. Study-related procedures and TMS provided at no charge to eligible participants.

PI – Glenn Currier, MD, MPH, Study Coordinator – Cristal Ruiz, BA, 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 – Kathy Smith, RN, 974-7006.

Memory and Seniors (Age 65+) Trials:

DEMENTIA, PARKINSON’S, ALZHEIMER DISEASE WITH NEUROPSYCHIATRIC SYMPTOMS

This 8-week, double-blind, placebo-controlled study is designed for individuals with dementia (any type) or Parkinson’s with neuropsychiatric symptoms, such as, delusions, hallucinations, depression, irritability, apathy, indifference, or sleep problems. A one-year open-label extension study is available. To qualify, patients must be 60 years or older, be experiencing neuropsychiatric symptoms, and have a partner or caregiver able to attend study visits.

PI – Jean Fils, MD, Study Coordinator – Kathy Smith, 974-7006.

MILD COGNITIVE IMPAIRMENT DUE TO AD

A double blind, placebo-controlled, 78-week study to determine the effectiveness of levetiracetam (Keppra XR) on MCI. Eligible participants ages 55-85 who have a caregiver/partner/friend available to attend study visits. PET scans, MRIs, labs, ECGs, study medication, and study visits provided at no charge.

PI – Jean Fils, MD, Study Coordinator – Kathy Smith, RN, 974-7006.

ALZHEIMER’S DISEASE WITH HALLUCINATIONS, DELUSIONS, AGITATION, OR AGGRESSIVE

A 16-week double blind, placebo-controlled study of an investigation medication to determine the effectiveness and safety on treatment of hallucinations, delusions, aggression, and/or agitation in individuals with Alzhemier’s disease. Eligible patients will be 50 years or older and have a caregiver who spends at least 4 hours per day with patient.

PI- Jean Fils, MD, Study Coordinator, Cristal Ruiz, BA – 974-2985.

Children & Adolescent Trials:

DEPRESSION

A 10-week study of levomilnacipran extended-release (ER) in adolescents, 12-17 years of age with Major Depression.

PI – Daniel Fallon, MD, Study Coordinator – Colleen Figueroa, BA, 974-9104.

ADHD WITH IMPULSIVE AGGRESSION

A 6-week study with an optional long-term extension study of an investigational medication for the treatment of Impulsive Aggression in patients with Attention Deficit/Hyperactivity Disorder in conjunction with standard ADHD treatment. Examples of Impulsive Aggression include arguing, cursing, yelling, threatening, throwing things, hair pulling, and hitting.There are two studies – one for children ages 6-12 years and another for ages 13-17 years.

PI – Daniel Fallon, MD, Study Coordinator – Colleen Figueroa, BA, 974-9104.

 

Please contact us at 813-974-1404 to learn more about clinical research trials at USF Psychiatry. 
All study related visits, procedures, and study-medications are provided.