Current Trials Open to Enrollment

Adult Trials:

MAJOR DEPRESSION DISORDER

A 6-week trial of an investigational medication (Rapastinel) given IV bolus as an add-on treatment for Major Depressive Disorder. Individuals 18 – 65 years with MDD who are currently on an antidepressant monotherapy and who have experienced less than a 50% improvement in depressive symptoms may be eligible. Oral antidepressant medication and study medication provided at no cost. This program will also provide up to six months in aftercare post study.

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

MAJOR DEPRESSION WITH SUICIDAL IDEATION

A double blind, placebo-controlled, inpatient study of an investigation medication given intranasal (esKetamine) in addition to current standard of care antidepressant medication. Individuals with Major Depression who are experiencing active suicidal ideations and are in need of inpatient hospitalization may be eligible. Participants must be 18-64 years of age and be willing to remain inpatient for 5 days.

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

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 – MANIIC, 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.

ADHD – NON-STIMULANT MEDICATION

This is a 9-week Double blind, placebo –controlled study of Viloxazine HCL in adolescents ages 12-17. Viloxazine HCL is a non-stimulant, which is being investigated for the safety and effectiveness in treating ADHD in adolescents.

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.