Clinical Studies

OSU Harding Hospital and the OSU Department of Psychiatry are committed to finding new treatments to decrease morbidity and mortality and improve the quality of life of patients with mental and behavioral disorders.

The clinical trials program at OSU Harding Hospital and the OSU Department of Psychiatry is one way to determine whether new treatments are safe and effective. The trials encompass agents that are in various phases of development across numerous diagnostic categories. Our goal is to ultimately establish new therapies to minimize the distress experienced by patients with an array of mental disorders.

Below is a list of ongoing clinical trials being conducted at OSU Harding Hospital and the OSU Department of Psychiatry as a part of a larger research program that includes pharmacology, genetics and imaging. These clinical trials, in adults and children, encompass diagnostic categories such as schizophrenia, bipolar disorders, depressive disorders, anxiety disorders, and Attention Deficit and Hyperactivity Disorders (ADHD).

Depression:

Protocol CAGO178A2304: “A 52-week, randomized, double-blind, placebo-controlled, multi-center, parallel-group study of the long-term efficacy, tolerability and safety of agomelatine 25 and 50 mg in the prevention of relapse of Major Depressive Disorder (MDD) following open-label treatment of 16-24 weeks.”

This investigational drug is the first in a new class of antidepressants which targets melatonin for adults 18-70 years of age.

Bipolar Depression:

Protocol A1281158: "A Six-Week, Double-Blind, Multicenter, Placebo Controlled Study Evaluating the Efficacy and Safety of Flexible Doses of Oral Ziprasidone as add-on, Adjunctive Therapy with Lithium, Valproate or Lamotrigine in Bipolar I Depression."

Research study of the effectiveness and safety of Ziprasidone in combination with a mood stabilizer (lithium, valproate or lamotrigine) for treatment of Bipolar I depression who are at least 18 years of age.

Anxiety:

Protocol A5361017: “A Phase 3, Randomized, Double-Blind, Placebo Controlled, Parallel Group, 10-Week Study Evaluating the Efficacy and Safety of PD 0332334 for the Treatment of Generalized Anxiety Disorder.”

Research study of an investigational medication for generalized anxiety disorder in adults ages 18-65.           

Schizophrenia:

Protocol DRI6726: “A 24-Week, Multicenter, Double-Blind, Randomized, Parallel-Group, Dose Ranging Study of the Efficacy and Safety of Oral Doses of AVE1625 5, 10, and 30 mg and Placebo on Top of an Established Treatment Regimen of Either Olanzapine, Risperidone/Paliperidone, Quetiapine, or Aripiprazole Monotherapy in the Treatment of Cognitive Impairment in Schizophrenia.”

Research study for adults 18-65 with stable schizophrenia who are being treated with an atypical antipsychotic.

Protocol AZD3480: “A multi-center randomized, placebo-controlled, double-blind, parallel group, phase IIb proof of concept study with 3 oral dose groups of AZD3480 during 12 weeks treatment of cognitive deficits in patients with schizophrenia.”

Research study for patients ages 18-55 with stable schizophrenia who are being treated with an atypical antipsychotic and who are active cigarette smokers.

For more information about any of the clinical trials listed above, please contact Betsy Miller in the OSU Department of Psychiatry at (614) 293-0195 or e-mail betsy.miller@osumc.edu.