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

__________________________________________________________________________________

COMP005 - COMP360 (PSILOCYBIN) FOR TREATMENT RESISTANT DEPRESSION

This 52-week study will evaluate the efficacy, safety, and tolerability of COMP360, a synthetic form of psilocybin, which will be orally administered with psychological support to those who have treatment-resistant depression (TRD). The study will compare 25 mg of COMP360 to placebo to determine the efficacy in improving depression symptoms for those who have TRD.  Study has an open-label component.

PI – Ryan Wagoner, MD

Study Coordinator – Mariah Nelson, RN, BSN 813-440-9428 | mariahn@usf.edu

__________________________________________________________________________________

RE104 FOR POST-PARTUM DEPRESSION

This 8-week study will compare 1.5 mg and 30 mg doses of RE104 administered under supportive conditions to adult participants with post-partum depression.

PI – Daniel Fallon, MD

Study Coordinator – Mariah Nelson, RN, BSN 813-440-9428 | mariahn@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-weekplacebo-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

Please check back – new studies opening in January 2025.

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 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 – Jordan Belliamy (813) 618-1074 | jbelliamy@usf.edu

ADHD Child Study – Opening Fall 2024-

A 9-week placebo-controlled efficacy, safety and pharmacokinetic study of evening dosed methylphenidate hydrochloride extended-release capsules (HLD200) in children with Attention Deficit Hyperactivity Disorder to evaluate whether treatment (20 and 40 mg) for 3 weeks provides superior ADHD symptom control or improves symptom severity compared to placebo in children aged 4 to 5 years.

PI – Daniel Fallon, MD

Study Coordinator – Jordan Belliamy (813) 618-1074 | jbelliamy@usf.edu

Bipolar 1 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 – Jordan Belliamy (813) 618-1074 | jbelliamy@usf.edu